Researchers employ cryocompression to prevent chemotherapy-induced peripheral neuropathy
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Chemotherapy-induced peripheral neuropathy is a potentially debilitating, often persistent adverse event associated with taxane-based chemotherapy.
Currently, the only proven method for relieving peripheral neuropathy is to reduce the dose of chemotherapy. However, this may have the unwanted effect of diminishing the potency of the treatment.
“There are concerns about whether or not [dose-reduction] could affect efficacy,” Kathryn P. Pennington, MD, an associate professor in gynecologic oncology at the University of Washington/Fred Hutchinson Cancer Center, told Healio. “We are very interested in what we can do to prevent peripheral neuropathy in our patients.”
Pennington and Melissa K. Accordino, MD, associate professor of medicine at Columbia University Irving Medical Center, have initiated a clinical trial comparing three approaches to prevent chemotherapy-induced peripheral neuropathy.
The ICE-COMPRESS trial, sponsored by the SWOG Cancer Research Network in collaboration with NCI, includes 25 sites and aims to enroll approximately 800 patients. Accordino and Pennington spoke with Healio about the approaches the study will investigate and their hopes for substantially lessening the burden of chemotherapy-induced peripheral neuropathy.
Healio: How are you conducting this trial?
Pennington: There has been very promising data out there, both for icing the hands and feet and for compression. These data suggest either of these techniques — or a combination of these techniques — could prevent peripheral neuropathy. However, no studies have definitively proven this. Despite both approaches being mentioned as promising techniques in ASCO and [European Society for Medical Oncology] guidelines, they aren’t recommended because there have been no high-quality randomized trials proving efficacy. That was our vision with this trial — to see whether we could move either of these techniques into the standard of care for our patients.
One of the exciting techniques uses a continuous-flow cooling device that delivers both compression and icing. One of the challenges with icing is that up to 30% of patients don’t tolerate it well — it’s too painful, and there have been cases of frostbite. People will often stop doing it. Also, the ice melts, and you have to keep replacing it. That’s a storage issue for infusion centers — patients might be asked to bring their own little coolers for storage. Lastly, icing doesn’t always provide uniform cooling.
A group of investigators in Singapore looked into ways of improving the delivery of ice-based approaches. They learned that when you give a little bit of compression cyclically, cooling is better tolerated. They were able to deliver the intervention at colder temperatures and for longer periods, and it appeared to be more effective. That’s what we call cryocompression. Our study compared cryocompression delivered through a device with continuous compression — which is another promising technique — or low cyclic compression, to see if any of these techniques would be better for preventing peripheral neuropathy.
Healio: What is the methodology of the ICE-COMPRESS trial?
Accordino: We currently have 23 patients enrolled. At enrollment, patients will be randomized into one of three treatment arms: cryocompression, continuous compression or cyclic compression. There are 25 sites that are participating and, so far, patients have been very excited.
Pennington: The study includes patients who are receiving specific taxane-based chemotherapy regimens. The device wraps around their arms and legs and delivers the intervention for 30 minutes before the taxane infusion, throughout the taxane infusion and for 30 minutes after. Patients would get this intervention for all cycles of chemotherapy. Our primary endpoint assessed the proportion of participants who developed clinically meaningful neuropathy using a standardized neuropathy questionnaire, which is a patient-reported outcome. There are many different ways to measure or report neuropathy — some determined by the physician, some assessed through neurologic testing and some reported by the patient. We think patient-reported [outcomes are] the most meaningful because they involve the patient’s experience. Thus, that is our primary outcome — whether there is a reduction in neuropathy with either of the two interventions compared with the control.
Healio: What are the long-term clinical implications of this study?
Accordino: We want to prevent patients from developing treatment-related peripheral neuropathy in the future. Our hope is that we can find an intervention that is easy to use, well tolerated and can be easily scalable for clinics. Our vision is to eventually have definitive proof that one of these interventions works well enough that it can and should be implemented as a new standard of care.
Healio: Is there anything else you would like to mention?
Accordino: For patients, this is a very feared side effect, and patients are doing whatever they can think of to prevent it. There are things people are ordering on Amazon, or they’re taking supplements or things that aren’t really proven. In terms of rigorous studies that have been done to look at prevention of chemotherapy-induced peripheral neuropathy, some of these approaches — including supplements — have been negative and actually shown to be harmful to patients. It’s important to us that we do a very well-designed study to get these answers, because this is a big need for our patients. We want to make sure whatever we are offering them is safe and effective.
Pennington: Finding something that can effectively prevent peripheral neuropathy would be a huge improvement for patients and would make a real difference in their quality of life.
Reference:
Valley-Mount Sinai Comprehensive Cancer Care welcomes first patient for ice compress clinical trial (press release). Available at: https://www.valleyhealth.com/newsroom/valley-mount-sinai-comprehensive-cancer-care-welcomes-first-patient-ice-compress-clinical. Published July 12, 2023. Accessed Oct. 10, 2023.
For more information:
Melissa K. Accordino, MD, MS, can be reached at Columbia University, 161 Fort Washington Ave., New York, NY 10032; email: mkg2134@cumc.columbia.edu.
Kathryn P. Pennington, MD, can be reached at University of Washington Medical Center, 1959 NE Pacific St., Box 356460, Seattle WA 98195; email: katypenn@uw.edu.
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