Results

Karen had thought about pulling an all nighter to get some projects done that she had been interested in doing, but we only stayed up a little later than normal. This turned out to be a decent decision because her treatments have been canceled and she is getting another week off. The scans have shown growth of several millimeters for many of the implants, along with new implants that weren't seen before. This has been passed off as "no significant changes" or sometimes even as "stable" in the past, but it's enough to tell the researchers the treatments likely aren't working. There are some cases where inflammation due to an immune response makes it appear as if the cancer were growing, but they don't feel that's the case here.

Karen asked and she is still the only person to undertake this clinical trial at Mayo. But even if others were on it I don't know if they would have been able to tell us if it were working for anyone else. The oncologist says going back on FOLFIRI is an option, but Karen feels strongly opposed to that idea. The oncologist believes the cancer was growing more slowly on while Karen was on traditional chemotherapy. I suppose there's even a chance things were worse because we were on this trial - a possibility I had never considered.

Directly afterwards I asked Karen how she felt, and she said fine, "but maybe it hasn't sunk in yet." Which is what's happened more as the day progressed. By evening she had become quite upset. Not to the point of tears, but to the point where it's certainly affecting her mood. She talked about it a little, and that helped. But what seemed to help the most was getting back to work on her projects. I guess the distraction is good.

There are other clinical trials we may be interested in. Right now the type of chemotherapy administered to cancer patients is based on the origin of the cancer. So Karen gets chemotherapy treatments that have historically performed best against colon cancer. This is FOLFOX and FOLFIRI. However, there are studies underway to use genetic testing on the cancer to catalog the gene mutations and choose a chemotherapy based on the specific genetics of the cancer. There is good reason to believe this is the better approach, but there still isn't a lot of data on it. One of the clinical trials Karen might qualify for is this sort of treatment. They'd do a fine-needle aspiration on one of the nodules suspected to be cancer, and map out it's dna. Based on the finding we'd try a specific chemotherapy treatment that's expected to perform better on Karen's particular variant of cancer.

Opposite Week

Last time Karen got a week off she had a good amount of energy and was actually quite active. This time around was nearly the opposite; she slept a lot and felt off most of the week. She even vomited Thursday. She managed to go two cycles of the clinical trial without puking once and now it happens on her week off. We figure she must have been fighting something all week because she didn't start to feel better until late Friday.

As I mentioned before, the CAT scan was Friday, but we won't be able to find out anything about the results until we see the oncologist Monday morning. I know we shouldn't expect much, this being a stage 1 trial, on the other hand it's hard not to get your hopes up. We talked about it briefly, and she says she doesn't have expectations one way or the other, nonetheless I'm worried she'll be overly disappointed if the scan doesn't show improvement. She doesn't seem to be nervous or thinking about it much, but she's also been keeping herself busy with things she wasn't able to do earlier in the week.

A Short Week

As I mentioned before, we would be getting Labor day off. This means Karen's first injection this week wouldn't be until Wednesday. Despite the side effects diminishing with each injection, when Karen started the second cycle her first injection was nearly as bad as the very first. So I was a bit concerned that with Monday off - making it 5 days between injections - that Wednesday's injection would be tough on her as well. Unfortunately, that did turn out to be the case. Which also meant Friday's injection was a bit rough as well. And some of the symptoms, particularly the painful sensations from air blowing over her skin, seems to have come back Sunday evening. Even on Monday she seemed overly fatigued. Karen's bloodwork hasn't shown the same drop in white blood cell count we saw the first cycle. This is almost certainly due to the extra day off, and quite possibly tied to the severity of her symptoms.

We have bloodwork and a CAT scan scheduled for Friday, but we won't find out if the injections have been working until Monday. Since it's easier to cancel an appointment than to try and schedule one at the last minute, they've already got Karen scheduled for her third cycle of injections. While on chemotherapy we never got scheduled more than a week ahead of time, but we seem to be scheduled a whole month ahead while on clinical trials. I assume this is to make sure they don't miss a treatment due to scheduling, but it feels strange to click on your appointment list and see it scheduled out all the way through October 7th.

The Second Second Week

This was the second week of the Karen's second cycle in the clinical trial. Much like the previous week, this week went very similar to that of the first cycle. Most of the symptoms seem to be slightly less severe than the first time around. For example, she still gets headaches but they don't seem to be triggering migraines, so she's better able to use her phone for texts. However, it turns out she's even more sleepy and fatigued this cycle. Wednesday's injection was the worst in regards to this. She went to bed around her usual time, maybe a bit early, but slept for around 20 hours. Then, after being up a few hours, slept again until Friday morning. I was starting to get quite concerned, but Friday's injection was much more typical.

At the end of the first week we got to talk to our research contact and one of the things that came up was the early appointments. He said there's no problem moving them further into the day. We thought noon would make things easier for us and they adjusted all of our future appointments accordingly. We were quite happy with the change and thought it would make getting to the appointments much easier on us. And it did, but it had one unintended side effect. During the first cycle, Karen would be fine the evening before her next injection, but now, with her injections happening 3 to 4 hours later in the day, she isn't recovering completely until bedtime. I'm not sure if the extra sleeping is related this schedule change, or if it's just compounding the issue. Karen says that for now she still prefers it later in the day - and compared to those 6:30am appointments across town, who wouldn't? - but maybe we'll aim for something in between for the next cycle.

Similar Week

The first week of this cycle was very similar to the first week of the first cycle. The muscle, bone, joint pains that seem to come from a sensitivity to a breeze have been less, but then again we've also been using ibuprofen from the start, and it does seem to help with such symptoms. There was less diarrhea and loose stools, but Karen didn't mind those side effects compared to the constipation she's been dealing with since her ostomy reversal. Overall, this first weeks' symptoms seems to be only slightly better than last time around. If I had to quantify it I'd say the side effects are maybe 15% to 20% less severe. And I'm not sure if it's not just because we are medicating better. Karen and I were also wondering if the severity of the side effects are in some way related to her white blood cell count - like how mosquito bites affect you less when your white blood cell count is lower.

First Injection, Again

Karen's first injection of this cycle started out well. She slept through what is usually the worst of it, but around 7 or 8pm she started to feel bad. And after I had just been saying how well she was doing and how smoothly things were going. I think part of it is that she was asleep and didn't take her acetaminophen and ibuprofen. I was worried that if I woke her up to take her pills, she'd be awake when her symptoms were at their worst. But it seems like it's going to be one of those things that are easier to stay ahead of than to try and catch up on later.

She said it was nearly as bad as her very first injection of the trial. There wasn't any nesaea this time though. This is most likely due to the olanzapine she takes the night before. But she ended up with a migraine around 8pm and had to take something for it. Her headaches seem to be connected to the neck pain and stiffness/tightness that she gets. Along with that she was also getting aches and pains like the first time around, and had a lot of sensitivity to moving air. I am still really puzzled by that one.

The symptoms improved over time, but slowly. I don't know if she just had a delayed reaction to this injection, or if it just took longer for things to clear up compared to the first time around. She didn't even seem to be feeling very well when she went to bed the second night, but seemed back to normal this morning. Of course she's pretty exhausted and worn out from the whole ordeal, but that's been a pretty consistent reaction to these injections.

The Next Cycle

On the days we have labs beforehand, the appointments start around 6:30 in the morning. So we have to leave before 6 to get there on time - maybe even earlier depending on traffic. Which means sometimes we have to get up around 5. And we've gotten use to staying up late this past week. So Karen was having a bit of trouble staying awake to talk to the doctors. Which I was worried might concern them, however, her blood work shows an increase in both white blood cell and platelet counts. They're lower than they should be, but they've gone up since her last lab work two weeks ago, and are high enough to start the next cycle. So Karen was OK'ed to start the next cycle of the clinical trial. She's mostly slept through it so far, which I think makes it easier on her.

For the most part, I have been rather impressed with the care we've been getting with Mayo Clinic and their attention to detail. But there's something about this clinical trial that just feels a bit off. I'm not sure if the research coordinators are only working for Mayo, and exactly how they're connected to the outside research. But sometimes it doesn't seem to be on the same level of professionalism that we've gotten use to at Mayo Clinic.

Today they had a calendar they asked Karen to help fill out, listing which side effects she had when. It was a bit odd to do, not only after our week off, but without having asked us to make notes or even suggesting we mentally note what happened which times. I probably could have pulled up the blog but the researcher seemed to be in quite a hurry and didn't seem all that interested in specifics. Afterwards, even without looking anything up, Karen was remembering things that had happened at different times, but what were we to do then? Perhaps they aren't as interested in side effects at this stage of the trial, but it felt unprofessional. Also, everyone is brushing off this unusual sensitivity to air that Karen often gets with the injection. It reminds me a little of the cold sensitivity she would get while on FOLFOX. I wonder if this will become a bigger issue if this trial stretches into the winter months.

Another thing that concerns me is the eye exams they administer at the start of the cycle. They have had to call us back after our appointment both times, as they had forgotten the eye exam. The excuse is that it's not a usually part of a clinical trial's testing. But that makes me a little nervous as to why someone thinks it's necessary here. At the very beginning, before we even signed any consent forms, I asked the research team why it's part of the trial and if there was any risk of blindness. They said they had no reason for concern, and that the only reason it was being done is because the sponsor wanted it done. The other thing is no one seems confident when they're doing the eye exam. The first time around I believe we had a visit scheduled with an ophthalmologist, but it was canceled and a researcher ended up taking a quick look at Karen's eyes. Today they asked the oncologist to look and he said he was unfamiliar with the particular type of ophthalmoscope that was available, but took a look anyway. Perhaps they are trying to save us some time or money, but I think I would have prefered the ophthalmologist visits.

Looking at the schedule, it appears there are no 7 hour observation periods this cycle. All injections have 2 hour appointments. They give her the acetaminophen (Tylenol) 30 minutes before the injection, and then observe her for an hour after the shots. That leaves some room for preparing the injection or unexpected delays, which seem to happen quite regularly. In theory we should be able to get in and out in 1.5 hours, but 2 hours is fairly typical. The other thing I noticed about the schedule is that we have Labor Day off. I realize the entire cancer clinic is closed on this day, but something about it still rubs me the wrong way. We had asked if Karen had to come in for 7 hours on her birthday, but were told we had to follow the clinical trial's schedule. This is a potential life extending or life saving drug, so the explanation seemed quite reasonable, but now with Labor Day off... I have to wonder if it was really necessary to have her in on her birthday, and if so, if the 7 hour day couldn't have been swapped with a different 2 hour day.