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

RECRUITINGN/ASponsored by Duke University
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2024-01-18
Est. completion2027-01-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions3

CancerChemotherapy-induced Peripheral NeuropathyGynecologic Cancer

Locations2 sites

North Carolina

1 site
Duke University Medical Center
Durham, North Carolina, 27710
Laura Havrilesky, MD919-684-0126laura.havrilesky@duke.edu

Virginia

1 site
Carilion Clinic
Roanoke, Virginia, 24016
Danielle Mitchell540-521-1355dmmitchell@carilionclinic.org

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