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.

NCT06139458

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

Recruiting
NAAges 18+InterventionalPrevention
Duke University
~190 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:CryotherapyCompression

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Measured over Up to two months after completion of chemotherapy, an average of 6 months
Gynecologic Cancer
Chemotherapy-induced Peripheral Neuropathy
4 sites across 3 states
Connecticut2
North Carolina1
Virginia1
  • Laura Havrilesky · PRINCIPAL_INVESTIGATOR · DUHS

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the Duke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

Exclusion

Treated with prior neurotoxic chemotherapeutic agents
Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
  • 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.