Cryocompression for Chemotherapy-Induced Neuropathy in Gynecologic Cancer
This study is looking at whether using cryotherapy (cold therapy) wraps combined with compression therapy (cryocompression) is as effective as cryotherapy wraps alone in preventing or reducing chemotherapy-induced peripheral neuropathy (nerve damage that can cause numbness, tingling, or pain) in women with gynecologic cancer. You could be eligible if you have ovarian, cervical, or endometrial cancer and are planning to receive at least six cycles of paclitaxel chemotherapy at Duke Cancer Center, Macon Pond, or Carilion Clinic in Roanoke, VA. The study aims to see if cryocompression is not worse than cryotherapy alone in improving your symptoms, as measured by a patient-reported survey called FACT-NTX. The study plans to include 190 participants.
- Study design
- This interventional study will randomly assign participants to receive either cryotherapy wraps plus compression therapy or cryotherapy wraps alone on their hands and feet. The study aims to enroll 190 participants.
- What's involved
- You would receive cryotherapy (+/- compression) during your taxane infusions. You would complete surveys about your symptoms, acceptability, and tolerability at each infusion visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms will be assessed up to two months after completing chemotherapy, which is an average of 6 months from the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
At a glance
Conditions
Where it's being run
4 sites across 3 statesStudy leadership
- Laura Havrilesky · PRINCIPAL_INVESTIGATOR · DUHS
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over timeUp to two months after completion of chemotherapy, an average of 6 months
The FACT-NTX is a patient self-reported 11-item questionnaire used for evaluating symptoms and concerns specifically associated with chemotherapy induced neuropathy. The total score ranges from 0-44, and a lower FACT-NTX score corresponds to worsening neuropathy. For both the FACT-NTX and the sensory subscale of the FACT-NTX, a significant decrease in the score is defined as a decrease exceeding 10% from baseline.