Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
Recruiting now · Not applicable
Conditions studied: Gynecologic Cancer, Chemotherapy-induced Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT06139458
- Run by
- Duke University
- People needed
- 190
- Starts
- 2024-01-18
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Middlesex Health Cancer Center - Middletown — Middletown, Connecticut, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Carilion Clinic — Roanoke, Virginia, United States (enrolling)
- Hartford Healthcare Cancer Institute — Hartford, Connecticut, United States
Full record on ClinicalTrials.gov
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