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RECRUITING
NCT05642611
PHASE3

Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

Summary

This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs. The 3 study approaches will use a device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress the arms and legs. This study may help researchers determine if any of the study approaches are able to prevent taxane chemotherapy from causing peripheral neuropathy.

Official title: Ice Compress: Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

777

Start Date

2023-06-06

Completion Date

2031-08-30

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood, plasma, and serum

PROCEDURE

Cryocompression Therapy

Undergo cryocompression

PROCEDURE

Pneumatic Compression Therapy

Undergo continuous compression

PROCEDURE

Pneumatic Compression Therapy

Undergo low cyclic compression

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (29)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Cone Health Cancer Center

Greensboro, North Carolina, United States

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

McLeod Regional Medical Center

Florence, South Carolina, United States

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

MGC Hematology Oncology-Union

Union, South Carolina, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States