Cryocompression for Chemotherapy-Induced Nerve Damage
This study is testing the Paxman Limb Cryocompression System (a device that cools and compresses your limbs) to see if it can reduce nerve damage (peripheral neuropathy) caused by taxane-based chemotherapy. Peripheral neuropathy can cause numbness, pain, or weakness in your arms and legs. You may be able to join if you are an adult over 18 with gynecologic or breast cancer, starting certain taxane-based chemotherapy regimens at DFCI. Researchers will look at how your nerve damage symptoms change, how long you can tolerate the cooling, and if there are any skin issues or changes in body temperature. The study is currently unclear about its status and plans to enroll about 50 people.
- Study design
- This is a randomized controlled trial with about 50 participants. You would have a 2 in 3 chance of receiving cryocompression during chemotherapy, compared to 1 in 3 chance of receiving standard care alone.
- What's involved
- You would undergo screening for eligibility, attend in-clinic visits, and complete questionnaires. The cryocompression would be applied during each chemotherapy infusion visit for up to 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your nerve damage symptoms will be assessed 1-4 weeks after your final taxane infusion.
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Cryocompression for CIPN
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Theresa Jabaley Leonarczyk, PhD, RN · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
- Leonarczyk · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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 TreatmentAssessed 1-4 weeks after the final taxane infusion (end of treatment).
Chemotherapy-induced peripheral neuropathy (CIPN) will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module (EORTC QLQ-CIPN20). This aim is defined as evaluating the incidence and severity of subjectively reported CIPN symptoms, including numbness, tingling, and pain in hands and feet. Clinically significant CIPN is expected to emerge during taxane-based treatment and will be captured at the follow-up visit post-treatment.
- Duration of Cryocompression Tolerated During Neurotoxic ChemotherapyUp to 12 weeks
Tolerance of cryocompression will be defined by the total amount of time (in minutes) the participant is able to wear cryocompression devices during chemotherapy infusions. This aim evaluates feasibility and tolerability from the patient perspective, based on self-reported ability to continue cryocompression throughout the infusion. Early removal or shortened wear time due to discomfort will be recorded.
- Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with CryocompressionThroughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks
This aim assesses the physiological safety of cryocompression. Core body temperature will be monitored orally before, during, and after cryocompression application, with any decreases greater than 1°F considered significant. Skin will be evaluated for intolerance signs (e.g., white or greyish-yellow discoloration, pain, tingling, numbness, or pressure) on cryocompressed limbs. The aim is defined as the absence of these adverse effects during cryocompression use.