Clinical Trial Risks & Side Effects

Okay, part of this is so T.M.I., but we need prayer people. So you have been warned.

Roger received a sixteen page document last Friday from MD Anderson regarding the clinical trial. It consisted of the informed consent and authorization to be a participant in research, a description of the research, a description of the study, potential benefits, alternative procedures or treatment and all the signature pages. Seven of the sixteen pages just covered the risks, side effects and discomforts to the participant of the clinical trial. Roger told me about one particular risk when he got home Friday which threw me for a loop for a bit. Then I sat down and actually read through the whole document. As I was reading through the pages and pages of risks and side effects and stating them out loud as I came across really “interesting” ones, I actually said to Roger, “Have you read this? And how do you feel about all of these?” There were definitely some scary ones.

But one threw us off the most. It was the risk Roger told me about when he got home from work. I kind of went off the deep end for a little bit. You see Roger and I have been praying since last year, okay, me more than Roger, about me getting on board with having a baby. Roger has been more ready than me since he had his first craniotomy in 2006. After he went through paralysis, living in a rehabilitation hospital to learn to walk and function normally again then 30 days of radiation, he told me he thought he wanted to have a kid and did not want to miss out on that experience. We had always felt like God had used us for many things and when it came to having children if God wanted to use us that way he would make it happen and we were fine with that. We both had not felt the passion yet to have children so we both agreed if we had kids we did and if we didn’t have kids we didn’t. No biggie until he shared this with me. So I told him at the time, “When you are really ready, let me know.” A few years pass and we are both finally back in Texas and decide to build a house. One month after moving in, Roger looks over at me and says he thinks he’s really ready now. And the praying began for me to get on board with that. Obviously more praying by me of course. I read a couple pregnancy/childbirth books last summer. And this past February we met with a midwife. That’s when I felt a tiny bit excited about the process. And since then have been praying for God’s direction on timing, etc. We thought we had a plan of me getting off birth control in June, watching for signs of ovulation for a month to make sure my body was all ready to go and begin the trying in August. Then at the end of February we found out about the questionable MRI results. We began to pray about and deal with that and also asked God to direct our plans for pregnancy. We didn’t know what we should do: go with our plan, start right away or put it all on hold. There were so many factors of Roger’s yet unknown treatment affecting what we should do. Was it tumor growing back and would he have surgery and be paralyzed permanently or worse coma or death? Would he have to have radiation or chemotherapy after surgery or in place of surgery that could affect his fertility? Or was it radiation necrosis and what the heck do you do with that? These are the wonderful things you get to think about and discuss with your spouse when you have cancer. Twice.

We knew we couldn’t make any decisions until after we went to MD Anderson. After we met with the neurosurgeon at MD Anderson in May, we thought our only option was surgery and we still couldn’t make a decision until we met with the neuro-oncologist. The Thursday before we were scheduled to meet him, we were hosting our weekly neighborhood dinner at our house. Roger and I were standing in the kitchen prepping for grilling pizzas with 10-12 of our favorite people, talking about anything and everything. And Roger says to me, “Why are we waiting? Why don’t we just start trying now?” So I said okay. I was already at the end of my birth control packet and would just not start the next one. The following Tuesday we meet with his neuro-oncologist who gives us three more possible options before surgery. So we think great, we have time. Thank goodness we started now. I specifically asked him will the drugs in the clinical trials affect Roger’s fertility and he says basically it could and we should look into banking some sperm. We had already discussed this option but were thinking we had plenty of time and could even keep trying while he was doing the clinical trial. Roger took the blood tests required for it the week before we went to see the neuro-oncologist just so that part of it was done.

Then Friday we get this sixteen page document and it clearly states at the end of the risks, side effects and discomforts paragraphs in its own little section that not only should he not father a child while on the study but he should not father a child for six months after the last dose of the study drugs and must use birth control. If his tumor responds to the study drugs he could be on the study for up to two years. What? I just got on board with having a baby and this happens?! The acceptable forms of birth control are birth control pills and/or condoms. Great, I just got off birth control pills. And if your partner becomes pregnant you must tell the doctors right away. Nice. There goes our chance of trying while he’s on the study and gives us about a month and a half at the most to try to get pregnant naturally. If we don’t conceive before he starts the study, he’s got to bank some sperm and then we can start the process of conceiving via artificial insemination or invitro fertilization. Two things I never thought I would have to do. Neither fun nor cheap. At this point I’m thinking I have to get pregnant before he starts the study because I don’t want to take the chance of getting pregnant while he’s on it for fear of what it would do to the baby. So for Roger’s sake, we better get pregnant before because I don’t think I want to have sex while he’s on the study if I’m not already pregnant. Poor Roger. So we are asking for prayer for us to conceive before he starts the study, for protection from all the risks, side effects and discomforts, for peace and strength to continue to make it through this, and that we seek God and glorify Him in everything.

Thank you, Holly.