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Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
About the study
The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.
What is being tested
- Cryotherapy (behavioral)
- Compression (behavioral)
Sponsor: Duke University · Participants: 190 · Started: Jan 18, 2024
Contact the study team
- Amelia Scott · Phone: 919-613-4584
- Mary K Anastasio · Phone: 225-603-7972
Official record on ClinicalTrials.gov — NCT06139458
Locations in the U.S.
| Connecticut | Hartford Healthcare Cancer Institute, Hartford (Not yet recruiting) Middlesex Health Cancer Center - Middletown, Middletown |
| North Carolina | Duke University Medical Center, Durham |
| Virginia | Carilion Clinic, Roanoke |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.