Monday, August 6, 2018

SO, you want to be on a Clinical Trial (prt Three)


Before we move to Part Three of my clinical trial experience, I must say a BIG THANK YOU to everyone who responded to my blog post regarding the death of my friend, Crystal. The post enjoyed an overwhelming readership rate (over 2,000 folks read the piece as of today) and I received so much love and support from folks across the country. You helped me to move forward. And that's all I can do. Today is Crystal's service in upstate New York. To honor her and to "be her voice", I will continue to post my journey for as long as I am able in hopes it educates those yet to experience cancer first hand, and to provide a level of comfort to those of us who fight this disease daily. You are NOT alone. Your voice will NOT be silenced. Ever. Well, I was actually "muted" for a period of time for "being rude" on one FaceBook page and almost removed from another last week as a result of the url of my blog, but all's good now (Crystal would have loved the ruckus)...and that's for another post!!! Ha! So, here we go.......and thanks for continuing to follow my journey. (jjb)

Before the start of the trial, I am required to give 16 tubes of blood. These tubes go to the “sponsor”, the researchers behind the trial, to use as a base-line of my health as the weeks, months and years of the trial go forward.

I’m met in the lobby by my entourage of clinical nurses, research assistants, and interns. Together we meander through the maze of the Medical Center to the CTU (the University of Miami's Sylvester Center for Cancer "Clinical Trial Unit") for the blood draw. Luckily, I had been pounding back liquids for hours, on the train, etc to be well-hydrated in preparation. As I sit waiting for the lady to take me back behind the CTU door, I begin to cry. Not exactly sure why. I guess it’s the overwhelming sadness of even having to do this shit. I’m not so much scared of what’s to come, but I am sad is has to be this way.

The clinical trial has a bunch of rules, or “protocols” that must be followed EXACTLY. Remember, the 280 participants in this trial, like most trials, are scattered across the country and receiving treatment at various cancer centers and hospitals. Keeping a handle on how each of us individually follow the rules to ensure a defensible, clinical rigorous outcome most be nightmarish to develop. This trial is a double-blind, two arm study. That means participants are “randomized” into one of two “arms” or teams as I like to call them. Both teams will receive 28 days of chemotherapy.

Yep, I will have gone thru my fourth round of chemo by the end. As you can imagine, this did give me some pause. Chemo is bad for you. It may save your life, but in doing so, it harms you. Some of the effects are reversible, some simply are not. The extreme fatigue I battle every day is a direct result of chemo. I still cannot feel the ends of my thumbs. My hair turned grey. My joints ache. I have developed arthritis in my sternum which affects my left shoulder. I remain hopeful it will lessen as the months and years go by, but there’s no guarantee. Some survivors develop heart, kidney and even leukemia years down the road following chemo. It is bad shit. But it saved my life and to try and keep me alive, I have volunteered to take another round.

The chemo is cyclophosphamide and is in a pill form this time and thankfully, not given by IV. I do not have to have a medical port put in again. And I take a pill twice a day. One week on, one week off, for 28 days. I had cyclophosphamide during my initial round of chemotherapy. The combination known as “A/C’, was paired with Adriamycin or the “red devil”. Awful shit that if spilled, would literally burn a hole in the linoleum floor. I’m told the cyclophosphamide is of a lesser dosage than my previous round and the risk of losing my hair or developing severe nausea as before is unlikely. I guess we will see.

I was given a bottle of cyclophosphamide pills. A bottle of 100 - exactly 100 pills.  Now mind you, I only need 28 pills in total (2 pills per day for 7 days – one week on one week off for four weeks). Why would I be given 100 pills when I only need 28? Still a bit of a mystery to me. Perhaps it will reveal itself as we go along. I’ve been given a document. I’m told it’s an official document, i.e. don’t lose it, and on it I must record the time of day, each time I take a pill, as well as writing down any symptoms, issues, etc. I experience. If I drop a pill, I need to keep it – not throw it way – and return it along with the other 71 remaining pills – and the official document - at the end of the first 28 days. The rules are ridged but I get it. The researchers have to do what they can to ensure some sort of standard protocol for everyone on the trial. Good thing I’m not a natural rule breaker!!!

After the initial 28 days of chemo, the two teams split. Team One will receive an injection of the trial vaccine (TPIV200) and sargramostim, which is more commonly used to decrease the chance of infection in people who have acute myelogenous leukemia or in people who are undergoing blood stem cell transplants, or for people who are undergoing bone marrow transplants. It works by helping the body make more white blood cells. Team Two will only receive the sargramostim. This is the “control” group. So, at the very least BOTH Teams receive the initial course of chemo, followed by an immune system booster for the duration of the study. The vaccines for both teams happen every 28 days for the first six months and then once every six months for next 3 ½ years. It’s a loooooong study. Before getting the vaccine, I will need to give blood and urine for testing and whatnot. Because the trial is double-blind, the I won’t know which team I’m on and my doctors don’t know which team I’m on. Apparently, the only time this is revealed is if I should have some kind of reaction or otherwise become pretty sick and only then, the researchers will notify my doctor. I have faith and will continue to believe throughout this trial that I am a member of Team One - the Team receiving the vaccine.

So, there you have it. That’s my clinical trial. I took my first chemo pill at 8:05am, Thursday, July 27th. So far, so good. #FuckCancer #KeepRooting4ME

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