Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Virginia
Carilion Clinic
NOT_YET_RECRUITING
Roanoke
Contact Information
Primary
Amelia Scott
amelia.lorenzo@duke.edu
919-613-4584
Backup
Mary K Anastasio
mm765@duke.edu
225-603-7972
Time Frame
Start Date: 2024-01-18
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 190
Treatments
Experimental: Cryotherapy
Experimental: Compression with Cryotherapy
Related Therapeutic Areas
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov

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