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

Last updated: February 24, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Vaginal Cancer

Pelvic Cancer

Treatment

Cryotherapy

Compression

Clinical Study ID

NCT06139458
Pro00106236_1
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomasof likely primary gynecologic origin based on cytology or FNA in conjunction withradiologic impression will be eligible)

  • Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at theDuke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patientsreceiving neoadjuvant chemotherapy with a plan for interval debulking will beeligible.

  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

Exclusion

Exclusion Criteria:

  • Treated with prior neurotoxic chemotherapeutic agents

  • Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, orconditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud'sdisease.

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Cryotherapy
Phase:
Study Start date:
January 18, 2024
Estimated Completion Date:
May 31, 2027

Study Description

Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Carilion Clinic

    Roanoke, Virginia 24016
    United States

    Site Not Available

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