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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Duke University • ClinicalTrials.gov ID: NCT06139458

Registry updated: 2026-10-05
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Description

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.

Interventions

  • Cryotherapy (Behavioral)
    Participants will receive cryotherapy on both hands and feet
  • Compression (Behavioral)
    Participants will receive compression on both hands and feet

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.

Conditions

Gynecologic Cancer Chemotherapy-induced Peripheral Neuropathy

Locations

  • Hartford Healthcare Cancer Institute — Hartford, Connecticut, United States
  • Middlesex Health Cancer Center - Middletown — Middletown, Connecticut, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Carilion Clinic — Roanoke, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record