Drug Trial

Many of you have asked for a follow up to my last post about the possibility of a drug trial.  Here is the latest:

• I DID get my port out on 10/29.  It was outpatient surgery at Piedmont.  The initial injections of local anesthesia were a bit painful (burning) but they did the job...numbed me right up.  It was a little nerve wracking for my surgeon to be literally right over my hear and cutting, pulling, sawing, but it didn't hurt.  He said some scar tissue had built up around the port (did I mention that it was in my body 449 days?!?) so I could feel him sawing the blade to cut through all of that and then pulling..a very weird sensation.  It ooh him a bit to get it out, but then he stitched me up and we went out for Mexican.  :)  I am getting better at this "being a patient" thing.  
• After initially going by myself down to Newnan to the Cancer treatment Center of America for the first round of assessments, Chris returned with me for Round Two.  In the first round it was just the usual, physical by an internal medicine doctor and review of entire medical history.  I met with part of the Research team and we went over the parameters of the trial in good detail.
• When Chris and I went together, we met with the whole research team and were impressed with the lead research doctor there.  He is Dr. Ricardo Alvarez, originally from Argentina (and for those of you who know me well you know I love accents of any sort!!) and his credentials are awesome.  You can read about him here: http://www.cancercenter.com/southeastern/doctors-and-clinicians/ricardo-alvarez/.  Mainly, he has devoted his career to advancing breast cancer medicines through extensive research, including a Fellowship and Professorship in breast oncology at M D Anderson in TX.  We learned that this trial will take place at 35 hospitals across the country, with only 5 participating at this location.  He confirmed that quite a lot of research has already been done on this drug, neratinib, and that it would have already gone to market if the side effects were under better control.  I was reassured to learn that the drug all participants receive to control the side effects is called loperamide, which is the scientific name for Imodium. This made me feel better...at least I wouldn't be "trying out" two new drugs.  Basically, all participants follow the exact same protocol, and the trial involves us simply reporting back, daily, how we are doing.  
• Cutting to the chase....we decided it was in my best interest to go forward withe the trial with the clear understanding that IF the drugs make me sick, then I will drop out.  The research team said it would not be a big deal for me to drop out, they would not pressure me to stay in.  In fact, that would be very telling for them if a patient cannot tolerate the drug.  
• So, they gave me a chest X ray and an EKG and I started the trial this past Monday, Nov. 2!!  I have to take SIX little pills (the cancer drug - neratininb) daily, and Six (spread throughout the day) of the loperamide for the first two weeks.  I have a little blackberry device that I have to document how I am feeling and what is going on with my stomach daily...must be uploaded by midnight every day.  It takes about 2 minutes to complete....no big deal.  
• I am happy to report a couple of things. First, the pills are small enough that I can actually swallow them.  I was so afraid they would be horse pills!  I struggle to swallow big pills.  Yes, another life skill that I missed out on.  :(  But second, so far so good!  I am on DAY 4 and so far I feel almost normal.  The information we reviewed said I might begin to experience "stomach issues" within a few hours or a few days of the first dose.  Everyone is "elated" (their words) that I am doing so well.  I am elated, too.  As with many drugs, the first month or two are supposed to be the hardest while your body adjusts.  I am so VERY THANKFUL that so far I have just carried on life as normal.  Last night I did have some mild queasiness and some rumbling of the tummy, but nothing happened.  I went to sleep and woke up feeling great.  I am keeping my eye on the prize.....this drug has been proven to reduce my chance of recurrence from ~15% within 5 years to ~10-11% (25-30% reduction in recurrence rate).  As I said before, these are not huge numbers, but when it's your LIFE, and there's something not too difficult to do to help increase your odds, and it falls in your lap, then I am thinking...hhmmmm, maybe I should pursue this?!?  Chris has been on the lookout for over a year just to see what is going on in the world of breast cancer research and nothing ever came along that would apply to me.  Then, all of a sudden my other treatments were ending and this trial popped up, within driving distance and I am the perfect candidate and it is a non-invasive, non-scary trial.  We prayed about whether we should do it and that is what caused us to put up the condition that we did (about not being willing to go back to the feeling terrible again).  But I do not believe it was a coincidence that this thing landed on our doorstep.  Even the research team were astonished that we found the trial because they had not yet publicized it.  I happen to be married to a super husband who has figured out where to go to find the latest news.  :)  I am confident that we have made the right move for now.  
• Meanwhile, we had a fabulous Halloween and I kept thinking back to how lousy I felt last year.  I dressed up but didn't have the energy to go trick or treating with the kids.  I enjoyed spending some time with our neighbors, but it wasn't the same as traipsing around the neighborhood and enjoying the moment with the kiddos.  Not even close.  
• So, I am on Day 4 and so far so good.  I can tell there is a little something weird going on in the gastrointestinal arena, but that is it.  So everyone, keep your fingers crossed that I continue to tolerate this drug well.  I'd like to at least be able to take it for a few months, as even that amount of time has been shown to be positive.  Time will tell.  As always, thanks so much for being interested enough to read and catch up on the latest health happenings.  Until next time....happy Fall!