Cryocompression for CIPN (NCT07064798) | Clinical Trial Compass
RecruitingNot Applicable
Cryocompression for CIPN
United States50 participantsStarted 2025-10-22
Plain-language summary
This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy.
The name of the device used in this research study is:
-Paxman Limb Cryocompression System (PLCS)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults \> 18 years of age
* Gynecologic or breast malignancy
* Starting 1st cycle of treatment with chemotherapy regimens:
* Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12, Q2 weeks paclitaxel X4 (preceded by doxorubicin/cyclophosphamide). (Breast Oncology)
* Q3 weeks paclitaxel/carboplatin X 6-8 (GYN)
* Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill)
* Able to complete questionnaires in English or Spanish
Exclusion Criteria:
* Previous exposure to neurotoxic chemotherapy
* Pre-existing neuropathy
* History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease
* Undergoing desensitization
* Lymphedema in the limb where the device would be applied
* Open skin wounds or ulcers of the limbs where the device would be applied
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient-Reported CIPN Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module at End of Treatment
Timeframe: Assessed 1-4 weeks after the final taxane infusion (end of treatment).
2
Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy
Timeframe: Up to 12 weeks
3
Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression
Timeframe: Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks