Guest blog: clinical trials – “Bugs” or “Shells”?
This is a guest blog from Allie about her experience of breast cancer clinical trials. Allie has her own blog: www.oneineight.info.
On my son’s ninth birthday, under the stifling Senegal heat, he saw the glimmer of blue water in a swimming pool, went running and dived in, only to surface screaming in horror as he was surrounded by dead tropical insects. As my six year old daughter and I cleaned the surface of the pool, we realized that there were many dead bugs on the bottom. Discouraged, hot and eager to cool off…she looked at me and said, “lets just pretend the bugs are shells.” We both laughed then jumped in knowing what we were getting into, but also thoroughly enjoying the cool water on sweaty bodies.
This sort of sums of my clinical trial experience. With anxious anticipation, I wanted to get my breast cancer treatment moving along so I could be done and move on with my life. I wasn’t ready to jump into a toxic treatment blindly; I needed to research the options, the side effects ( bugs) and outcomes (cool water and shells) so that I could complete treatment with as little trauma as possible and a similar quality of life as I had before treatment.
At 42, I looked death in they eyes – diagnosed with stage IIIB, ER+ and BRCA 2+ Invasive Ductal Carcinoma Breast Cancer; my organic and healthy body faced chemo, surgery and radiation and post treatment hormone blockers. The nerd that I am, started digging into the details which led me to Mayo Clinic in Minnesota. My BRCA2+ status made my relationship with Mayo bidirectional – I wanted to stay alive and could use the best team possible and they could research me as a subject in clinical trials….we opened the door to each other to learn and buy me extra time to enjoy my children and all the bug and shell moments that life brings with it.
As I navigated the treatment plan I learned more about the history of breast cancer treatment and wanted to acknowledge all of the women and men before me who joined clinical trials to give others a better chance of survival; My participation in clinical trials as a BRCA+ survivor allowed me to give back and inform future treatments for others.
My first oncology appointment included a briefing on clinical trial options – meeting with project coordinators and frequent conversations with my oncologist about which trials make the most sense considering my diagnosis and quality of life objectives. I had hard choices to make, including types of chemo (as there was a trial on Cisplatin vs. Adriamycin and Cyclophosphamide (AC) and BRCA+ Breast Cancers) as well as studies involving pharmaceuticals to reduce cardiac damage during AC, lymphedema studies and even studies related to lymph dissection. After many calls with my oncologist, clinical trial screenings and countless nights spent researching treatment options. I enrolled in my first of many clinical trials which was the “Preventing Anthracycline Cardiovascular Toxicity with Statins.” My chemo would be delayed a few days so I could consented to further blood tests, 3D cardiac CT scans, health questionnaires and cognitive assessments. I also needed to take a pill everyday that could be a placebo or could be Lipitor and needed to do this for 3 years. Since I am a bit of a data geek…having blood work and CT imaging as a baseline also informed me with evidence of my health before and after BC treatment so I felt that it would mutually benefit me even if the “pill” did not.
I popped my pill daily from a gigantic white pill bottle not knowing if it was the placebo or the real thing. I avoided reading the side effects of Lipitor as I didn’t want to have any psychosomatic reactions. The trial was very patient-centric so I had frequent calls with the trial team and felt that everyone was really interested in my outcomes and grateful for my participation in the study…this motivated me a bit as I really hated getting my chemo infusions but seeing my team was always informative.
After my first chemo infusion, I had a severe reaction where I could not stand up as my BP was so low, had severe muscle pain and could not read as my eyes were jittery – I called a friend thinking that chemo was “ making me brain dead”. Then..it occurred to me that it could be the clinical trial drug. I read the side effects of Lipitor, then called the project coordinator who notified the Principle Investigator (PI). I was instructed to stop the clinical trial meds and see how I feel after a few days. My symptoms disappeared and I was convinced that the clinical trial drug was actually Lipitor and not the placebo and my body just couldn’t deal with the toxicity of both chemo and a new pharmaceutical. After the second infusion, I felt ok, the PI followed-up with me and asked if I wanted to restart with the pharmaceutical. I was a bit nervous to tell her, “No,” but when I did, she was professional and fully respected my decision. In the end the PI, kept me in the study and continued with all fo the labs, questionnaires, cognitive tests and scans which will not only inform their study but provide me with valuable information in terms of my cognitive and heart health functions.
Each quarter, I am contacted for one of the many studies I am in for follow-up (via the bio bank which has both my healthy and cancerous breast tissue, the lymphedema study or general BC studies).
At Mayo, I met countless men and women who were in trials that saved their lives, I also know of the other stories where women and men are not briefed on trials or denied access to a potentially life saving trial because of their age, gender or type of cancer. I grapple with fury that there are such disparities globally in terms of access to potentially life saving clinical trials but realize with research there has to be a line drawn somewhere and hope that this line will include minority populations and those who could benefit the most. Another important group that we need to remember includes the women and men who were on a trial that lost their lives only to prove a new treatment option didn’t work…as a survivor I bow down to them in tearful gratitude as they have informed research so that others can live.
The first step to accessing trials is your oncologist. In my opinion, if your oncologist is not aware of clinical trials, then you should get a new oncologist. They may work in a health facility that does not have ongoing trials for breast cancer, but they should be aware of research to inform their decision making as professionals. Women can also research current trials on the ClinicalTrials.gov website which is a registry of all clinical trials in the USA by location. Another option is to look up cancer research institutes such as Mayo and find out who to contact for trial options. In my experience the project coordinators are always eager to discuss with patients as it is their job to recruit subjects.
My experience with clinical trials has overall been positive as I feel a part of the eventual cure. At the same time, I acknowledge that it isn’t for everyone and it can also add stress to an already life challenging moment. You may never know which arm of the study you are in (control group or not) and if what you are taking/doing will benefit you, make you worse or have no change at all. To this day, I still wonder if my odds of surviving BC would be higher if I would have enrolled in the PARP Inihibitor study or the Cisplatin study…but at the time, I had to listen to my gut (with a dash of my oncologists wisdom) and my intuition told me it wasn’t the right thing for me at that time in my life. Enrolling in the study fully informed from professionals and your own gut feelings will keep you from diving into the clinical trial surprised or worse surrounded by bugs.