The last 10-14 days have been pretty lousy, with nearly perpetual nausea (sometime more severe, sometimes less) and increased fatigue. This has also made eating difficult, and Penny has lost 10 pounds. We're at the clinic today for an unscheduled appointment to decide how to handle the situation.
The best guess is that Penny is metabolizing the drug faster than she is getting rid of it, so it has been building up over time and has now gotten to a level that she isn't tolerating. The plan is to give her some IV fluids and nausea meds, to explore some options for other nausea meds she can take at home, and to discontinue the study drug for one week to give her body a chance to recover a bit.
Depending on how things go over the next week, the hope is to resume the drug (perhaps at a reduced dose) next week. So the hope is that we can get the nausea under control and have a good food week.
I asked whether the study dose is based on patient weight or a standard dose. As I expected, it is a standard dose. In effect, this means that Penny is getting a larger relative dose than most subjects because she is lighter than most. It's possible that that is part of the issue. Of course, this is a clinical trial, so there isn't a lot of dosage data available at this point.
(Interesting side note on blinding in clinical trials: Although blood is drawn to measure the level of the drug in her blood, those blood samples are sent to the central study team and the results are not reported back to us or to the clinical team in Grand Rapids. So we don't have lab work to indicate if/how the drug levels have been increasing over time.)
The next scan is scheduled for August 21, and shortly after that will be another decision point about how to proceed.
Comments
Stacey Wieland: Praying you can find resolution to the nausea and that Penny will get lots of nutrition this next week!
Dawn Mulder: Sorry to hear you’ve been feeling unwell. Prayers for restoration with this break and a way forward
Marie VanderLinde : So sorry to hear of the struggles with nausea and fatigue. Praying for relief during the break and a way forward that is gentler.
Randall Pruim: Since the drug is new and only 20-30 people in the world are taking it, it wouldn't surprise me if the assay is custom and not readily available except at the study site, but I don't really know. It's possible that the drug is similar enough to other drugs that something could be adapted. The plan is to use symptoms as an indicator for now. I'm sure they will also be in contact with the study center between now and next week since they need to discuss possible options for dose modification, etc.
Mike Borst: Thanks for the update - I was wondering how the trial was going! Praying for resolution of the nausea, and wisdom in moving forward. That is a interesting tidbit about the blinding (necessary) and the lack of lab feedback (unfortunate). Can your local doc check the medication levels, or is that a specialized test that is not readily available?
George Monsma, Jr.: Sorry to hear about the problems. Praying for good nausea control and good nutrition, and wisdom for you and the medical team as you proceed.
Chriss Pruim: thank you for updating randy.🤍 will be praying for the nausea to subside and that the treatment will be successful.
Terri A Boer: Continued prayers for Penny and the family
Patricia Boer Fischer : Prayin🙏 Y'all BIG Time, Thank-U So Much 4the Updates on Penny, Prayin Everythin Falls n2 Place w-the treatments, God Bless Ya's both, Hugg's & Love ❤️ from Tennessee!! Cousin Patricia Fischer 🙏😘💕
Alisa Tigchelaar: Praying for nausea control and a good food week, Randy and Penny. And that God will lead and guide the doctors in charge of determining the right next (reduced) dose. Much love. 💗
Jamie Munson: So sorry to hear this. Paige and I are praying for the nausea to subside quickly.
Susan Langeland: Praying with others here for an end to the nausea and tiredness. It sounds like a really rough week and we pray that your body can recover without the meds and that you will be able to eat, Penny. Praying for you and the rest of the family, too, Randy.
Teri Warners: I an so sorry to hear Penny hasn't been feeling well the last 2 weeks. Praying for peace and comfort for you both and your family, and that you will get some good advice on how to proceed.
Tony Holmes Curran: This sounds miserable. I’m so sorry. I’ll be praying for relief for you, Penny. I understand the need for blind trials of new treatments, but it so frustrating that this can’t be tailored to give you the best care possible. I pray for a way forward that fits what you need.