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

NCT05642611 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 777

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Malignant Solid Neoplasm

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Melissa K Accordino · SWOG - Columbia University

  • Katherine Pennington, MD · NRG - University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2030-08-01
Completion
2031-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05642611 on ClinicalTrials.gov