When It Comes to Cancer, Unknown is Unacceptable…

Molecular profiling, biomarker testing and targeted therapies are changing the way physicians treat cancer patients.  In the not-too-distant future, experts agree that cancer will be defined and treated based on each person’s unique molecular profile and biomarkers rather than the body part where it first originated.  Until this happens, oncologists must rely on knowing the part of the body where the cancer started (known as the primary site) to guide their treatment plans.


So what happens when a person is diagnosed with cancer and doctors do not know it’s primary site?


Each year 45,000 – 75,000 US cancer patients are diagnosed with metastatic disease but the primary site (the part of the body where the cancer started) cannot be determined. This is known as “cancer of unknown primary” or CUP.  In some instances, physical examination, detailed blood tests and various imaging scans can help determine the primary tumor location.  In other cases, doctors are forced to use their best guess and treat accordingly. As a result, the prognosis of patients diagnosed with CUP is poor.


If you’ve been diagnosed with Cancer of Unknown Primary, check out the Rosetta Genomics Cancer Origin Test. The Cancer Origin Test uses highly sensitive technology to measure the level of microRNAs in a tumor sample to determine the primary tumor location.


How accurate is the Cancer Origin Test? In a nutshell, I’d say it’s pretty darn accurate.  In a study of 509 tumor samples, 82% of the samples tested using the Cancer Origin Test produced a single predicted origin with 90% accuracy.  In another study, 84 CUP patients were tested and results from 77 patients predicted a single origin with 92% accuracy.*


The Bottom Line… The origin of your cancer can have a big impact on your treatment plan.  If you’ve been diagnosed with Cancer of Unknown Primary (CUP), ask your doctor which test(s) he or she plans to use to diagnose your cancer.  The Cancer Origin Test can yield results in just 4-7 days enabling doctors to provide patients with their best treatment options quickly.  If your doctor is not familiar with the Cancer Origin Test, let them know about it. The right diagnosis can save your life. 


BTW, many insurance companies including Medicare now cover this testing. For those patients who may not be able to afford testing, Rosetta Genomics has a Patient Assistance Program (PAP).   For more information, call their Customer Service at 1-215-389-9000 or US Toll Free at 1-888-522-7971.


*Rosetta Genomics
*Meiri E., Mueller W.C., Rosenwald S., A second-Generation MicroRNA-Based Assay for Diagnosing Tumor Tissue Origin, The Oncologist 2012
*Pentheroudakis G, Pavlidis N, Fountzilas G, et al. Novel microRNA-basedassay demonstrates 92% agreement with diagnosis based on clinicopatholoic and management data in a cohort of patients with carcinoma of unknownprimary. Mol Cancer June 2013


10 Biggest Cancer Clinical Trial Myths BUSTED


According to the National Cancer Institute, less than 5% of adult cancer patients sign up for cancer clinical trials.  But how is this possible if clinical trials are considered the backbone of medical research?  It may boil down to the fact that many people have misconceptions about what clinical trials are and how they operate.  In fact, I have been guilty of this… I remember when our Oncologist suggested a clinical trial for Alan’s sarcoma… I immediately assumed that meant we were out of treatment options and at the end of our rope.

Fast forward to today… I read a fantastic article on cancer clinical trials written for the Cleveland Clinic’s Health Hub, a free health information website and eNewsletter.  It was so good that I’m reposting the article below … after all, knowledge is power.  Let’s share the power!

“People have a lot of misconceptions about cancer clinical research trials. They might think patients mostly just take sugar pills instead of receiving actual treatment.  Or they may think clinical research studies are only for people who have no other options.

These and many other common beliefs about cancer clinical research trials are simply not true, says Joshua Beaver, Research Program Manager for Solid Tumor Oncology at Cleveland Clinic.

Mr. Beaver and his colleagues lined up a list of the Top 10 myths that they frequently hear about clinical trials and set about shooting them down one by one:

Myth 1: Participating in clinical research provides no benefit to me as the patient

In fact, trials give patients access to the latest drugs and procedures. Studies show that patients who participate in clinical trials have outcomes at least as good, if not better, than the general patient population.

Myth 2: My doctor can tell me whether or not to consent to clinical research

A physician’s job is to help a potential clinical research patients weigh the pros and cons and otherwise educate them.  Your doctor can’t give you a “yes” or “no” answer or try to predict whether a particular treatment will work or not. Instead, think of your doctor as a helpful resource in making an informed decision.

Myth 3: Researchers treat patients like guinea pigs

This is far from the truth,” Mr. Beaver says, mentioning a survey finding 97 percent of trial participants experienced respectful treatment and care exceeding their expectations.  Often, patients will not even feel like they are part of a study because clinical trials incorporate the best available medicine. Researchers will then adjust treatment to see if enhancements can improve patients’ quality of life or response rates.

Myth 4: Clinical research patients are taking sugar pills

Researchers never use sugar pills in place of the best known treatment for a given cancer, and they are very rarely used in clinical cancer trials whatsoever, Mr. Beaver says. “Patients who join clinical trials will never sacrifice quality of care.”

Myth 5: Health insurance won’t cover the cost

Check with your carrier but the chances are good that coverage will extend to the full cost of your treatment.

Myth 6: Cancer clinical research studies are for people who have no other options

Sometimes clinical trials are a last resort. But many times they simply involve a simple addition or adjustment to a standard treatment plan that can provide patients with a better quality of life.

Myth 7: You need to live near a major hospital to participate

Many clinical trials take place at regional hospitals. “Some trials even extend to local cancer clinics and doctor’s offices,” says Mr. Beaver.

Myth 8: Informed consent exists primarily to protect researchers’ legal interests

Informed consent provides patients with information about their rights as a participant to help them decide whether to participate. Mr. Beaver adds, “The consent process is actually designed to avoid ‘legalese’ and to make absolutely sure that it is understandable to everybody.”

Myth 9: Once you sign the informed consent form, you’re legally bound to participate

Patients have the right to decline participation at any time. Their doctors will then switch to the standard treatment for their condition.

Myth 10: Patients can’t expect medical personnel to keep them informed

Physicians, medical professionals and research staff are all available at any time to help patients. “We know and appreciate that patients’ willingness to participate is what makes cancer trials possible,” Mr. Beaver says.”

(Source: Health Hub from Cleveland Clinic)

Check Out Cleveland Clinic’s FREE Clinical Trials App

Cleveland Clinic has created a free Clinical Trials app for cancer patients to keep abreast of their 130+ active cancer clinical trials. This Cancer Clinical Trials app is available for both Apple and Android devices.

With this app, you can:

The app also includes contacts for patient resources, financial services information, support groups and treatment guides.

Getting the 411 on Breast Reconstruction


The Cancer Support Community surveyed 762 breast cancer survivors (who were eligible for breast reconstruction) and found that 43% of these women did not receive any info about breast reconstruction PRIOR to making surgical decisions (mastectomy or lumpectomy).  Why is this a huge problem?  Well, if you opt to reconstruct one or both boobs, the method you choose to reconstruct can be affected depending on how the initial surgery is done.  Since you can’t go back and re-do your mastectomy, this is an extremely important conversation to have with your doctor BEFORE a mastectomy takes place.


Whether you’ve been diagnosed with breast cancer or have a family history of breast cancer and/or the BRCA gene and are contemplating a mastectomy, check out BreastReconstruction.Org, the most comprehensive site on breast reconstruction that I’ve come across.


To provide a better understanding of the breast reconstruction process and the different options that exist, BreastReconstruction.Org has created a site that contains easy-to-understanddetailed information with illustrations and photographs on topics including: mastectomy; options for reconstruction; secondary procedures including nipple tattooing; pre and post operative care; as well as the latest news & information on reconstruction.  You can also read stories from other women who have walked in your shoes and learn from the decisions they have made.  It’s really a fantastic site.


BTW, my dear friend and kick-ass breast cancer survivor Diane Mapes (AKA @Double_Whammied) just wrote an incredible article on her breast reconstruction using the BRAVA/ fat transfer method.  To read about Diane’s experience, see her article “Reconstructing Hope.  Diane also blogs about breast cancer at





Champions Oncology & Sarcoma


I’ve had the pleasure of working with some of the organizations I write about in this blog; others I wish I had known about during our “cancer journey”; and still others, although not relevant to Alan’s cancer are fantastic resources that can help others in their fight against cancer.


Champions Oncology is one of the organizations that we were lucky to find. Their co-founder Dr. David Sidransky is one of the smartest and most dedicated cancer warriors I know. Champions is doing great work to help fight cancer… one person at a time. Watch this YouTube video above about a man who was diagnosed with sarcoma to learn more.  And click HERE to see what I wrote about Champions based on my personal experience.

10 Reasons Why I’m a Fan of The Cancer Treatment Centers of America


For years I’ve seen television commercials for The Cancer Treatment Centers of America (CTCA)But are they really as good as they appear to be?  I’ve visited their Arizona facility twice and I have to say, I think they might be that good. If nothing else, I’m impressed with the way they attack cancer (and I don’t get impressed easily ;-))…


Below are 10 reasons (listed in no particular order) of why I’m a huge fan:

1.  Practice personalized medicine.  CTCA treats each cancer as unique and tailor a treatment protocol to match each person’s unique needs and diagnosis.  CTCA will run genetic and biomarker testing on tumors.  They will even prescribe off-label drug treatments (drugs that are not part of the standard protocol) if the standard of care is not doing the job. They also take a proactive approach to treating side effects caused by cancer treatments.


2.  Integrative team approach.  Every patient at CTCA gets a team of at least 5 professionals assigned to care for them including a medical oncologist, clinic nurse, registered dietitian, naturopathic clinician and nurse care manager.  Of course, surgical specialists, radiation oncologists, gastroenterologists, etc. will also become part of the team if their areas of expertise are required.  And get this, they all talk to each other and create a joint plan of action together.  They work together to treat the entire person before treatment begins, during treatment and even after treatment ends.   CTCA also employs licensed acupuncturists and massage therapists to help patients manage the side effects of treatment.


3.  100% focused on cancer.  Need I say more?! BTW, approximately 65% of the people being treated at CTCA have advanced or complex cancers. They are used to tough cases.  And they don’t give up.


4.  Make having cancer a little less stressful.  Schlepping from one doctor to the next; coordinating care and communications between different doctors and different hospitals; tracking down records, getting prescriptions, battling with insurance, etc. is downright exhausting.  At CTCA, they do all this for you.  You show up to your appointment and your team of doctors come to you.  


5.  Latest & greatest equipment.  CTCA offers cutting edge, treatment options and state-of-the-art technology like Cyberknife, TomoTherapy®, Cord Blood Transplants, Calypso® 4D Localization System™/GPS for the Body®, Tuning Fork, genetic & molecular profiling & much more.


6.  Nutritious & delicious food.  If you’ve ever eaten hospital food, you know how much it sucks.  Sorry, but it does.  The food they serve at their facilities is A-M-A-Z-I-N-G.  It’s all freshly prepared, made from organic ingredients whenever possible and inexpensive (I swear).   Each facility has it’s own smoothie bar and serves Starbucks coffee (seriously).  The Arizona facility even has it’s own organic farm.


7.  Works with many insurance companies.  CTCA works with many different insurances (typically not medicare or medicaid though).  All costs are pre-determined so there will be no surprise charges.  Acupuncture, reiki, chiropractic and other mind-body work are included, even if these services are not covered by your insurance carrier.


9.  Incredible amenities.  On-site pharmacy; on-site boutique specializing in wigs, head shavings, head coverings & mastectomy products- all sold at 30% below retail; on-the-premises spa; 24X7 visiting hours; really nice private hospital rooms that are ICU-capable with nearby subsidized hotel rooms for approximately $40 a night; massage & pampering for caregivers; only green products are used to clean the center; all medical records & results are 100% digital; really nice infusion bays; pet therapy dogs, free laundry services; the list goes on and on.  They even throw parties to celebrate different milestones throughout this journey.


10.  Survivorship programs.  Once active treatment is complete, CTCA Survivorship Program lends support to survivors as they get back into the swing of things.


THE BOTTOMLINE:  CTCA treats every patient as a person, not a number.  They take personalized cancer care to a new level…  They offer realistic hope to their patients.  I wish we had looked into receiving treatment there for Alan.

Brain Tumor Clinical Trial Registries from All Over the World



The International Brain Tumor Alliance (IBTA) has created a list of brain tumor clinical trial registries available online.  Although some of these resources are specific to brain tumors, others are not.  I am reposting this information as this listing is one of the most comprehensive that I have seen.  Thank you IBTA!  BTW, if you know of a clinical trial registry that is not listed below, please email Chris at   I just emailed them about an Immunotherapy Clinical Trial Finder I know of.  Knowledge is power…. we gotta share the power….

International Clinical Trials: is a registry of federally and privately supported clinical trials conducted in the United States and around the world. gives you information about a trial’s purpose, who may participate, locations, and phone numbers for more details.


WHO International Clinical Trials Registry Platform (ICTRP)

The World Health Organization Clinical Trials Search Portal provides access to a central database containing the trial registration data sets provided by multiple registries from around the world. It also provides links to the full original records.


Current Controlled Trials Ltd

Current Controlled Trials Ltd is part of Springer Science+Business Media. In response to the growing body of opinion in favour of prospective registration of controlled trials, the Current Controlled Trials website was launched in 1998, aiming to increase the availability, and promote the exchange of, information about ongoing randomised, controlled trials worldwide.


IFPMA Clinical Trials Portal

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Clinical Trials Portal aims to ensure:

A free and easy-to-use interface for patients and health professionals alike to ongoing clinical trialsclinical trial results and complementary information on related issues; Non-promotional and reliable information; Industry’s commitment to the transparency of clinical trials.



Pan African Clinical Trials Registry

The Pan African Clinical Trials Registry (PACTR) is a regional register of clinical trials conducted in Africa. The registry is an African initiative serving the needs of Africans. It provides a searchable, electronic database of planned trials and trials currently in progress.


South African National Clinical Trial Register

The South African National Clinical Trial Register provides the public with updated information on clinical trials being conducted in South Africa.



Chinese Clinical Trial Registry (in Chinese and English)

The Chinese Clinical Trial Registry (ChiCTR) was established by the Chinese Ministry of Health as a national clinical trials register to join the WHO International Clinical Trial Registry Platform (ICTRP).


National Clinical Research Coordination Center (in Korean and English)

Information on clinical trials being conducted in Korea.


The Clinical Trials Registry – India

The Clinical Trials Registry – India (CTRI) is an online register of clinical trials being conducted in India. The CTRI was set up by the ICMR’s National Institute of Medical Studies (NIMS) and funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR).


Japanese Clinical Trial Registry (in Japanese)

This portal is intended to provide information on clinical trials registered in three major Japanese centers: University Medical Hospital Information Network (UMIN); Japan Pharmaceutical Information Center (JAPIC); and the Japan Medical Association Center for Clinical Trials .


Sri Lanka Clinical Trials Registry

The Sri Lanka Medical Association (SLMA) has taken the initiative to establish the Sri Lanka Clinical Trials Registry (SLCTR), which will provide a facility for registration of trials conducted in Sri Lanka or overseas, and for collaborative research between Sri Lankan and foreign researchers.

Australia and New Zealand:

Australian Cancer Trials

This is a free information service that displays the latest clinical trials in cancer care, including trials that are currently recruiting new patients. The website is updated each day with new information from the Australian New Zealand Clinical Trials Registry from the United States.


Australian New Zealand Clinical Trials Registry

The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online registry of clinical trials being registered in Australia, New Zealand and elsewhere.


Cancer Trials Australia

Cancer Trials Australia (CTA) is a clinical trial network spread across multiple sites. CTA provides a fully comprehensive oncology clinical trials service that includes the conduct of single or multisite clinical trials, ethics submissions, research governance, clinical development advisory and laboratory assay services.


Victorian Cancer Trials Link

The Victorian Cancer Trials Link (VCTL) is a searchable database of all cancer clinical trials being conducted in Victoria.


Cancer Trials New Zealand

The overarching objective of Cancer Trials New Zealand (CTNZ) is to contribute to the New Zealand Cancer Control Strategy commitment to improve cancer control through research and clinical trials.


EU Clinical Trials Register

The EU Clinical Trials Register website allows you to search for information on clinical trials in European Union (EU) member states and the European Economic Area (EEA) and clinical trials which are conducted outside the EU/EEA if they form part of a paediatric investigation plan (PIP). The website is hosted by the European Medicines Agency (EMA).


EORTC Brain Tumour Group

The EORTC Brain Tumour Group is a multidisciplinary and international group of neurosurgeons, neurologists, medical oncologists, radiation oncologists and basic scientists, and aims to conduct, develop, coordinate and stimulate research on the treatment of primary and secondary brain tumours.


Internet Portal of the German Clinical Trials Register (DRKS)

The DRKS is an open access online register for clinical trials conducted in Germany, which allows all users to search, register and share information on clinical trials.

Nederlands Trial Register (in Dutch)

Het NTR is een openbaar toegankelijk en vrij te doorzoeken prospectief trialregister, waarin studies staan geregistreerd die lopen in Nederland of worden uitgevoerd door Nederlandse onderzoekers.


Karolinska Clinical Trials Registry

The Karolinska Clinical Trials Registry is a Swedish online register of clinical trials being undertaken at the Karolinska University Hospital and other hospitals in Stockholm county.


United Kingdom:

Cancer Research UK

Cancer Research UK maintains a database of cancer trials written for patients, their families and friends. They aim to list all trials recruiting cancer patients in the UK.


UK Clinical Research Network Portfolio Database

The National Cancer Research Network (NCRN) maintains a searchable database of eligible clinical studies, known as the NIHR CRN CC Clinical Research Portfolio, which comprises the National Institute for Health Research (NIHR) Portfolio in England, and the corresponding portfolios of Northern Ireland, Scotland and Wales.


United States:

CCR Clinical Trials at NIH

The Center for Cancer Research (CCR), NCI’s largest division doing research on campus, conducts brain tumor clinical trials at the NIH Clinical Center in Bethesda, MD.


Coalition of Cancer Cooperative Groups

The Coalition of Cancer Cooperative Groups is a nonprofit organization whose mission is to improve the quality of life and survival of cancer patients by increasing participation in cancer clinical trials.



Since December 2000, EmergingMed has guided more than 170,000 patients through a search for cancer clinical trials.


Pediatric Brain Tumor Consortium (PBTC)

PBTC’s mission is to contribute rapidly and effectively to the understanding and cure of these tumors through the conduct of multi-center, multidisciplinary, innovative studies with design and analyses based on uniformly high quality statistical science.


Radiation Therapy Oncology Group

For 40 years the Radiation Oncology Group (RTOG) has been a recognised leader in working to increase survival and improve the quality of life for cancer patients. Based in Philadelphia, RTOG is a key clinical research component of the American College of Radiology (ACR) and serves as a multi-institutional, international clinical cooperative group funded primarily by the National Cancer Institute.



Used by the American Cancer Society, TrialCheck is a clinical trial database of all federal (U.S.) registered cancer studies and will identify a trial that fits your needs – completely unbiased. Please note, the search facility requires a U.S. zip code.

The Virtual Trials website is one of the most comprehensive sources of information and support for brain tumour patients available online. The website contains a search facility for clinical trials and noteworthy treatments for brain tumours.


The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

The Preston Robert Tisch Brain Tumor Center website has a list of all the brain tumor clinical trials available at their Center.


Cedars-Sinai Medical Center

Cedars-Sinai has one of the largest state-of-the-art clinical research facilities of any private hospital in the US.


The CERN Foundation

The CERN Foundation (Collaborative Ependymoma Research Network)  is comprised of a dedicated group of scientists and adult and pediatric neuro-oncologists working to find new treatments for ependymomas. Clinical trials are an integral part of the CERN Foundation’s many projects and collaboration.


City of Hope Clinical Trials On-Line

City of Hope is recognized worldwide for its compassionate patient care, innovative science and translational research, which rapidly turns laboratory breakthroughs into promising, new therapies. It is one of only 40 National Cancer Institute-designated Comprehensive Cancer Centers nationwide and a founding member of the National Comprehensive Cancer Network.


University of Pittsburgh Cancer Institute (UPCI)

Summaries of clinical trials ongoing at the Univeristy of Pittsburgh Cancer Institute are available on the Clinical Trials section of their website.



Amgen Trials is dedicated to bringing information about Amgen’s clinical trials to patients and healthcare communities.


Antisense Pharma GmbH

Information on clinical trials run by Antisense Pharma, including the phase III SAPPHIRE study on Trabedersen (AP 12009).


AstraZeneca Clinical Trials

This website provides clinical trial data, results and other information from or regarding AstraZeneca-sponsored clinical trials.


Boehringer Ingelheim International GmbH

Comprehensive information on new and ongoing confirmatory clinical trials sponsored by Boehringer Ingelheim are provided Results of Boehringer Ingelheim-sponsored trials can be found on their Trial Results website.


Bristol-Myers Squibb Clinical Trials Registry

This website lists clinical trials for which Bristol-Myers Squibb has full disclosure responsibility.


Celldex Therapeutics

Celldex has four programs currently under clinical evaluation for the therapy of cancer, including CDX-110 for glioblastoma multiforme (GBM).


Eli Lilly and Company Clinical Trial Registry

This site contains information and links about clinical studies sponsored by Eli Lilly and Company.


Glaxo Smith Klein Clinical Study Register

This register provides summary protocol information for GSK sponsored clinical studies.


Merck & Co. Inc.

Merck (operating as MSD outside the U.S. and Canada) register all of their trials on Information about ongoing clinical trials is also available through the IFPMA Clinical Trials Portal.


The Merck Group

Merck KGaA and its division for innovative small molecules and biopharmaceuticals, Merck Serono (operating in the US and Canada as EMD Serono ) carry out a series of clinical trials, all of which are registered on



The Novartis clinical trials website (for U.S. residents only) is designed to inform the public about important medical research studies as well as to educate patients and caregivers about the clinical trial process. For clinical trials outside the U.S. all Novartis clinical trials are registered on

This site contains information on clinical trials involving the NovoTTF device from Novocure Ltd.


Peregrine Pharmaceuticals Inc.

Peregrine Pharmaceuticals is a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections.


Roche Clinical Trial Protocol Registry and Results Database

The Roche clinical trials database contains information about clinical trials sponsored by the Roche Pharmaceuticals Division and the Roche Diagnostics Division. The website is hosted by a third party, CenterWatch, to ensure impartiality.


Tocagen Inc.

News and updates on clinical trials run by Tocagen Inc., which is developing an innovative therapeutic approach to the treatment of glioblastoma multiforme (GBM).


Disclaimer: Please refer to IBTS’s disclaimer regarding the information provided on their website.

Study Shows 1/2 of Early-Stage Breast Cancer Patients Can Safely Avoid Chemo When Using MammaPrint


If you have been diagnosed with early-stage breast cancer, talk to your doctor about The MammaPrint breast cancer test.  


According to the recently published RASTER Study, The MammaPrint breast cancer test (developed by Agendia) can accurately determine which early stage breast cancer patients are at low risk of breast cancer recurrence and can therefore safely choose not to undergo chemotherapy. Furthermore, the study suggests that half of early-stage breast cancer patients may be able to safely avoid chemotherapy.


Here’s the dealio (as my daughter always says)…

427 breast cancer patients were studied over 5 years. Of the 219 patients who were determined to be ‘low risk’ based on the MammaPrint test, 85% chose not to have chemotherapy. Of those patients, 97% were disease-free after 5 years. Of the 208 patients who were determined to be ‘high risk’, 81% chose chemotherapy and 91% were disease-free after 5 years.  This is the first breast cancer genomic study to include 5-year outcome data.


The MammaPrint test analyzes 70 critical genes identified in breast cancer metastasis (3x more genes than previous-generation testing); can be used on both hormone-receptor-positive or hormone-receptor-negative early stage breast cancers; and has been FDA-cleared in the US.


For more information, visit  If you don’t have insurance or your insurance company doesn’t cover MammaPrint testing, contact the Agendia Cares Program as they may be able to help.  To compare MammaPrint against other genetic assay tests such as Oncotype DX or Mammostrat, speak with your doctor and visit


(Sources:  Agendia PR ;, MedScape, European Cancer Organization)

Top 10 Questions to Ask When Considering a Clinical Trial- part 2 of 2


MEET GUEST BLOGGER Tory Zellick.  Tory Zellick, CMT blogs about careviging for The Huffington Post and has been a featured expert on CNN, ABC and NBC. When she was 18, Zellick was like every other high school graduate – until the day her mother was diagnosed with breast cancer. Suddenly, with no prior experience or training, Zellick found herself responsible for managing all aspects of her mother’s care. Not only did Zellick start keeping track of everything related to her mother’s medical, legal, and insurance matters, but she went so far as to study massage – empowering her to lower her mother’s pain levels. Now a decade later and three years after her mother’s passing, Zellick has published The Medical Day Planner: The Guide to Help Navigate the Medical Maze. Available at Barnes & Noble and on Amazon, the book is a step-by-step, ailment-neutral guide on how to tackle each aspect of caring for oneself or a loved one who is ill.  To learn more, visit Tory’s website


I recently posted an article, “Top 10 Facts You Need to Know about Clinical Trials.” Now, let’s explore the top questions you need to ask clinical trial leaders — including the principle investigator and the medical team — so as to effectively evaluate and support your loved one through a specific clinical trial that your loved one is considering.**

1. What do you know about this drug or procedure?
Be sure to find out how many animals and/or people have been tested to date; what the results were; what phase of testing the clinical trial is in; and the safety profile of the drug or procedure – including possible adverse reactions. Ask about a website where you can find out more information about the history of this clinical trial.

2. What are some possible benefits and risks?
Find out exactly how the treatment might improve your loved one’s condition in the best-case scenario, and identify the risks involved — everything from adverse to fatal reactions. Ask about how the treatment may affect your loved one’s quality of life, and find out what symptoms to look out for and whom to call in case of side effects: What changes should you note and report immediately?

3. What are the protocol requirements?
Find out how many appointments will be required weekly, monthly and overall; how long the appointments will be; where the appointments will be held; what procedures, tests or scans will be involved; what specific challenges these may pose for your loved one; how many medications will be required; how frequently the medications will need to be administered; and what data will need to be tracked and how often. Ask if there are other protocol requirements you should know about.

4. What is the structure of the protocol?
Ask the study coordinator how many individuals are participating in a given trial and what the guidelines are for that trial. Find out if there will be a placebo group and who, or what, will the results be compared to. Determine what exactly the investigators are looking for in the trial, and therefore, at what point the treatment will be terminated. For example, are the investigators looking for halting the progression of disease or for catalyzing the remission of disease? If the disease continues to metastasize or progress, will the patient therefore be eliminated from the study?

5. Who is responsible for the study?
Ask about the credentials of the primary investigator and medical team, and find out how many studies they have conducted in this field and regarding this particular health condition.

6. Who pays for what?
Find out which expenses are covered by the clinical trial, which may be covered by your health insurance company (be sure to verify with your insurance representative) and which will be out-of-pocket.

7. Will we have access to the treatment?
See if this clinical trial offers a compassionate drug use program. If it does, your loved one will have access to the treatment before it is available in the market, assuming s/he has responded well to the treatment during the trial.

8. Are there possible contraindications?
Make sure the principle investigator and medical team are familiar with all the therapies your loved one is using. If they are not, see if they will speak with your loved one’s healthcare providers, to evaluate whether there are possible contraindications. Make sure you know if certain treatments must be stopped before participation in the trial.

9. What is the ultimate goal of this study?
Find out how the information from the study will be used, and ask about the next steps after the clinical trial.

10. What are some other options?
In case this clinical trial does not seem to be a good match, ask the trial leaders what other options might be available to your loved one.

As you consult with your loved one and weigh the pros and cons of participating in the trial, do include your own needs as a factor to consider — specifically, the feasibility of the extra caregiving duties required by the clinical trial. Do also share your honest thinking about the various risks and benefits of the trial. Keep in mind, however, that the decision is ultimately your loved one’s to make; after all, it is her or his own life at stake, and therefore, choice to make.

**Special thanks to:
John SchallCEO Caregiver Action Network
Ken Getzfounder and board chair of the Center for Information and Study on Clinical Research Participation (CISCRP)
Craig LipsetHead of Clinical Innovation at Pfizer Worldwide Research & Development
Dr. Sean Mackey, MD, PhDChief of the Division of Pain Management at Stanford University
Rebecca McCuedivision research manager of the Stanford Systems Neuroscience & Pain Laboratory (SNAPL)

Top 10 Facts You Need to Know about Clinical Trials… part 1 of 2


MEET GUEST BLOGGER Tory Zellick.  Tory Zellick, CMT blogs about careviging for The Huffington Post and has been a featured expert on CNN, ABC and NBC. When she was 18, Zellick was like every other high school graduate – until the day her mother was diagnosed with breast cancer. Suddenly, with no prior experience or training, Zellick found herself responsible for managing all aspects of her mother’s care. Not only did Zellick start keeping track of everything related to her mother’s medical, legal, and insurance matters, but she went so far as to study massage – empowering her to lower her mother’s pain levels. Now a decade later and three years after her mother’s passing, Zellick has published The Medical Day Planner: The Guide to Help Navigate the Medical Maze. Available at Barnes & Noble and on Amazon, the book is a step-by-step, ailment-neutral guide on how to tackle each aspect of caring for oneself or a loved one who is ill.  To learn more, visit Tory’s website


Medical institutions, federal agencies, pharmaceutical corporations and patient advocacy organizations conduct thousands of clinical trials annually, and according to John Schall, CEO of the Caregiver Action Network,family caregivers are the backbone of the clinical trial experience. “Caregivers predominantly act as care managers,” he explains. Among other roles, “they make sure appointments are kept, and they manage medications and medication regimens — both compliance and adherence.” Learning about the world of clinical trials, however, is akin to learning to speak a new language, and it can be overwhelming to both caregiver and care recipient – especially in the middle of a health crisis. So here is a simple breakdown of the top 10 facts you need to know about clinical trials:

1. What are Clinical Trials?
Clinical trials are a combination of interventional studies and observational studies conducted on volunteer patients. Interventional studies research how drugs, procedures, devices or lifestyle modifications affect a select group of patients with a common health condition. Observational studies research trends among select patients, through comparing released medical data and healthcare records or through monitoring a group with a common health condition. For example, investigators may observe a select group of women to learn about the effects of different lifestyles on adrenal health. Although observational study participants are not assigned an intervention as part of the study, they may continue with whatever interventions are part of their routine care, such as pharmaceutical prescriptions.

2. Why Conduct Clinical Trials?
The purpose of clinical trials is to develop and bring to the market new and effective treatments for disease.

3. How Common Are Clinical Trials?
In 2006 alone, there were about 15,000 drugs in the research and development (R&D) pipeline (1) and about 2.5 million clinical trial volunteers.(2)

4. Who are the Players in a Clinical Trial?
Key players are the trial sponsor, who pays for the study; the principle investigator, who oversees the research; medical staff including doctors, nurses and social workers, who work directly with patients and collect data; the caregivers, who oversee patient compliance with clinical trial protocol; and the patients, who are the subject of study. “Patients and caregivers are the heart and soul of this research,” says Craig Lipset, Head of Clinical Innovation at Pfizer Worldwide Research & Development. “No new medical advances would be made without them.”

5. Why Might My Loved One Choose to Participate in a Clinical Trial?
According to Ken Getz, founder and board chair of the Center for Information and Study on Clinical Research Participation (CISCRP), there are numerous reasons to participate in a clinical trial — from access to new and alternative treatments, to personalized and expert medical attention, to free medicines and procedures, to the desire to leave a legacy by helping the advancement of medicine. “Participants may know in their heart of hearts that [a specific treatment] will not cure the progression of their disease,” Getz elaborates on the latter reason, “but if they participate, they may be able to help future patients.”

6. Where Do I Find Out about Clinical Trials for My Loved One’s Health Condition?
First, contact a patient advocacy organization that is ailment-specific to the condition affecting your loved one, and ask about clinical trial options. For example, if your loved one has Alzheimer’s, contact the Alzheimer’s Association. A simple internet search using the formula of “[disease name]” + “association” should pull up some of the top national advocacy groups. Second, visit the National Institutes of Health website on clinical trials, to find a list of upcoming research studies looking for volunteers. Third, contact CISCRP for information about, plus the added bonus of support throughout, upcoming clinical trials.

7. Does Participating in a Clinical Trial Mean Stopping Other Medical Therapies?
In some cases, there may be contraindications between therapies already being used and the therapies that will be used in a clinical trial. It is imperative to let the clinical trial medical team know exactly what therapies a loved one is receiving, whether prescribed or over the counter. These therapies may include drugs, supplements, bodywork, dietary modifications and so on. The medical team, in some cases in combination with the care recipient’s own doctor or holistic health provider, will determine which therapies can be continued and which may need to be stopped before participating in the clinical trial.

8. How Risky Are Clinical Trials?
According to Lipset, observational studies — such as the sharing of medical files — typically pose no added risk, and the risk of interventional studies depends on numerous factors. For example, if two known drugs are being compared to see which is more effective in the treatment of a particular illness, the risk is low. It is important to note that even if a medication is FDA approved, an individual may suffer adverse side effects. If an unknown drug is being tested, however, the risk depends on how far along that drug is in the R&D phase: The more it has been tested, the less risky it is. Even tried-and-true drugs or procedures may be risky, adds Rebecca McCue, division research manager of the Stanford Systems Neuroscience & Pain Laboratory (SNAPL), such as in the case where an FDA-approved drug is used to treat an illness other than that for which it was approved.

While holistic intervention such as cognitive behavioral therapy poses negligible risk, other alternative medicine therapies may pose some risk. “A number of alternative therapies don’t go through approval with the FDA,” explains Sean Mackey, MD, PhD, Chief of the Division of Pain Management at Stanford University. For example, he says, nutritional supplements are unregulated by the FDA and therefore “have not been through the close scrutiny that pharmaceuticals go through. The vast majority are not dangerous agents, but we simply don’t know their long-term safety and efficacy…We haven’t studied a lot of these over-the-counter supplements in large-scale trials, because there are not drug companies interested in doing that.”

To determine the exact risks associated with a particular clinical trial, experts agree, it is important to speak directly with the principle investigator and medical team of the trial your loved one is considering.

9. What steps are involved in evaluating the safety and efficacy of drugs used in clinical trials?
Pharmaceutical trials begin with years of pre-clinical research in laboratories, followed by testing on animals and concluding with several phases of testing on people. Before moving from one stage of research to another, the clinical trial team must submit an Investigational New Drug application (IND) — through which both the Food and Drug Administration (FDA) and independent ethics committees review results, prior to authorizing the continuation of the study. When a study begins working with people, it starts off with a small group in Phase I and steadily increases the number of people involved, until Phase IV — where the research team begins exploring additional indications for that drug. After completing Phase IV, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market. Of the 5,000-10,000 drugs that annually enter R&D, only 250 make it to pre-clinical trial testing; only five make it to clinical trial testing; and only one makes it to FDA approval.(3)

10. How involved should I be in my loved one’s decision to participate in a clinical trial?
To ensure the safety and quality of life for your loved one, get actively involved in evaluating the pros and cons of participating in a clinical trial. For starters, your loved one “may struggle to understand and weigh the risks and benefits” of participating in a trial, says Lipset, so by gathering and sifting through all the relevant information ahead of time, you can explain exactly what is involved. In addition, agree Lipset and Schall, you can help your loved one recognize and evaluate the impact not only of the risks and benefits of the treatment itself, but also of the protocol demands of the trial — including travel requirements, financial commitment, time constraints and additional caregiving duties. Be sure to discuss issues that affect not only your loved one, but also yourself, advises Schall, since you will be a central player on the clinical trial team.”

Check back tomorrow for Tory’s post on “Top 10 Questions to Ask When Considering a Clinical Trial”.  Knowledge is power.  Share the power!  

Breast Cancer Treatment Turns Tumors Into ‘Balls of Ice’

Could freezing breast cancer tumors be a viable alternative to breast cancer surgery? Possibly.  A procedure called cryoablation  (a process that uses extreme cold to destroy or damage tissue) has been used for years to treat both malignant tumors (in lung, prostate, kidney & liver cancers) and other benign tumors.  Now, some experts believe that cryoablation may also have the potential to replace surgery for some breast cancer patients.

Here’s how it works…

In cryoablation, a needle that has been cooled to -274F (-170C ) with liquid nitrogen is repeatedly inserted into cancerous tissue.  The cancerous tumor turns into a “ball of ice”.   As it defrosts, the cancerous tumor is destroyed.  The procedure only takes about 15 minutes to perform, requires no general anesthesia, and can be done on an outpatient basis with minimal scarring.  Researchers say that they can use cryoablation to target tumors up to the size of a golf ball.


Using cryoablation therapy to treat breast cancer is currently in clinical trial: 

  • lists a phase 2 clinical trial studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer.  Click HERE for more info.  This trial is currently recruiting patients. (For additional information, also visit Sanarus, the maker of the cryoablation equipment used in this study).
  • There is also a clinical trial in Japan underway for patients with early stage breast cancer being treated with cryoablation therapy. (For additional information, visit IceCure Medical, the maker of cryoablation equipment for this study.)


(Sources:  Yahoo News; Mayo Clinic; IceCure Medical)