Thursday, July 10, 2008

Clinical Trial

After an early radiation appointment this morning, I drove downtown for my Herceptin treatment and to begin my enrollment in a clinical trial. I haven't mentioned anything about this trial on my blog, but I have been diligently researching it behind the scenes to determine if participating was worth it. Unlike the other studies I have done, this is a trial. That means I will be taking a medication for a lengthy time (3 years) to determine if it will help reduce the risk of recurrence in women with early stage breast cancer who are in remission. I've asked many doctors and nurses who are and who are not connected with my current treatment; I've spent many evenings looking at the potential risks and benefits of the drug; I've prayed about it; I've discussed it with my husband. I say all of this to ease concerns of friends and family who are reading this. My decision to enroll was taken with great care. As with any clinical trial, if I find I do not tolerate the drug well or for whatever reason decide to stop, I can do that.

So the first obvious question is......What drug am I going to be taking?
The answer.........Bisphosphonates. These are the same drugs prescribed for osteoporosis, only at greater dosages. The clinical trial is looking at three different bisphosphonates to determine which one can provide the best benefit with the least amount of side effects (which are mostly gastrointestinal in nature). Bisphosphonates are currently being used to treat patients whose cancer has spread to their bones. There are already some good results from other trials indicating that bisphosphonates can reduce recurrence for women with early stage breast cancer.

The next probable question is.......Why? Why would you do this?
The answer.........That's hard to explain completely, but here are some of my thoughts:

*I'm 37 years old and, because of my decision to remove my ovaries, I am in menopause. I believe my oophorectomy was the right choice for me. Taking Vitamin D and calcium combined with eating healthy and exercise are good options to keep my bones healthy, but taking hormones to help maintain my bone health is not an option. So, I'm at risk for osteoporosis. I see a benefit in taking the bisphosphonates. I don't know when my days will be numbered (only God does), but I want to be as healthy and as strong as I can be for however long He grants me....just like my Great Grandma Vivian, who was treated for breast cancer in her mid-50's and was a survivor for over 40 years!!!

* A few Saturdays ago I met a woman I didn't know. We were at the All-Alumni weekend of our Alma mater......alumni of the same college, but having graduated nearly 30 years a part from one another. She noticed my short hair, quietly came up to me and gently said, "May I ask you a personal question?.....Is your hair just starting to grow out?" Of which I answered, "Yes." She proceeded to tell me that she was a 5 year survivor and had been one of the women who took part in the Herceptin clinical trial. The results of that trail made a big impact in the oncology world. Up until that time there was not an effective treatment for women whose cancer was Her2 positive. It was because of her courage and the many women like her, that I am blessed to be receiving Herceptin today. I had been asking God to confirm in my heart which may I was to go forward with the bisphosphonate clinical trial. I truly felt that the unlikely meeting of this woman and me was ordained by God.

* Strange, but true.....I had a physical therapy appointment just a few days after Trevor had broken his arm. While the PT was working out some of my scar tissue, I was telling her about Trevor's unhappy event. She looked at me and said, "Does he have osteogenic imperfecta type A like you do?"........I had no idea what she was talking about.....so I asked, "What do you mean?" She said, "Well, the whites of your eyes have a very mild blue tint to them. That's a fairly good sign that you have a mild form of it and you could have passed that on to your son." She's a very knowledgeable lady and had in fact studied a family with two girls who'd had this same genetic defect. Apparently every summer the two girls would end up with a broken bone of some sort. Now, I don't know if Trevor or I really do have this bone imperfection, but I do know that of all my sisters I've had the most broken bones (and of all his brothers, Trevor holds the record). Regardless, it made me think, "I may really need these bisphosphonates more than I know."

* I'm sure I could tell you many more things about how this decision was made........but I can't remember them right now!!!! Except, I have gained about as much knowledge as is possible in finding out more about it, I have prayed about it and asked God to give me direction and discernment and wisdom, AND I have submitted the whole thing before my husband who has given me his blessing in moving forward.

Sooooooooo, I started the clinical trial today. After a creatinin blood test to make sure my kidneys were working properly, I was randomized to one of three arms of the trial. That means that this trial is studying three different bisphosphonates. Neither I, nor my doctor have the option to choose which one I take. It's chosen by the computer. One of the drugs is given intravenously (once a month for 6 months, then every 3 months after that....for 3 years). The other two drugs are in pill form and are taken orally every day for 3 years. Considering the fact that I have a nice new PowerPort, that I'm to avoid blood draws from either arm for quite some time and therefore needed a good reason (in my own mind) to keep my port after my Herceptin infusions end in January, AND that I hate the idea of taking a pill EVERY DAY for 3 years (I'm already taking more than I'm used to)......I was hoping for the IV drug.

Annnnnnnnnnd, (written that way because I know that I take way to long to explain things and I'm just as happy as you that this blog entry is coming to an end) that's what I got. The IV form of the bisphosphonate!!!!!

Whew! Well, it's been a long day.....Radiation....Herceptin....Zometa......dead tadpole (oh, that's whole other tale that won't be told tonight.....Sorry, Beth....We were not good tadpole keepers).

Before I sign off: Thank you, Hillary, for keeping my younger two boys all day. Thank you, Sandy, for joining me for lunch on a day that you could have gone home early from work. And, to Mr. and Mrs. G, thank you for the wonderful stew, biscuits and dessert. What a blessing to come home to some good home cooking!!! I'm so sorry I missed seeing you.

1 comment:

jan said...

Wow Michelle-
you are brave. I'm really, really blessed, convicted, and impressed by how you've handled everything you've gone through in the last year. And now to be willing to be a part of a clinical study...
Anyway-I also wanted to apologize for being a pill at the meeting on Wednesday. I hadn't slept well the night before and sometimes sleep deprevation turns me into someone I don't even want to be around.
Like I said, if I'm causing problems or rocking the boat, please, please let me know!
Thanks for blogging-
Judy