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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Duke University
Study ID
NCT06139458
Status
Recruiting
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Conditions

  • Chemotherapy-induced Peripheral Neuropathy
  • Gynecologic Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryotherapy — BEHAVIORAL
    Participants will receive cryotherapy on both hands and feet
  • Compression — BEHAVIORAL
    Participants will receive compression on both hands and feet

Study Details

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 Dates

Start date
Jan 18, 2024
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cryotherapy
  • Experimental: Compression with Cryotherapy

Primary Outcome Measure

Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time [ Time Frame: Up to two months after completion of chemotherapy, an average of 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Hartford Healthcare Cancer InstituteHartfordConnecticut06106
Corey Glider
[email protected]
860-972-5019
Amy Brown, MD (PRINCIPAL_INVESTIGATOR)
Middlesex Health Cancer Center - MiddletownMiddletownConnecticut06457
Loriann MacLean, MSN
[email protected]
860-358-2015
Karthikeyan Kandevelou, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Laura Havrilesky, MD
[email protected]
919-684-0126
Laura Havrilesky, MD (PRINCIPAL_INVESTIGATOR)
Carilion ClinicRoanokeVirginia24016
Danielle Mitchell
[email protected]
540-521-1355
Erin Saks, MD
[email protected]
(540) 581-0160
Erin Saks, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Hartford Healthcare Cancer Institute· Hartford, CTMiddlesex Health Cancer Center - Middletown· Middletown, CTDuke University Medical Center· Durham, NCCarilion Clinic· Roanoke, VA

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