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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Malignant Solid Neoplasm
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States, 35233

Martinez

Contra Costa Regional Medical Center, Martinez, California, United States, 94553-3156

Atlanta

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Honolulu

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States, 96826

Kansas City

University of Kansas Cancer Center, Kansas City, Kansas, United States, 66160

Overland Park

University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States, 66211

Westwood

University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States, 66205

Lexington

Baptist Health Lexington, Lexington, Kentucky, United States, 40503

Clinton Township

Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States, 48038

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must have a diagnosis of a solid tumor malignancy.
  • * Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid tumor malignancy within 3 calendar days after randomization.
  • * Weekly paclitaxel x 12 consecutive weeks
  • * Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
  • * Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
  • * Docetaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery NOTE: For any of the protocol-specified chemotherapy regimens, concurrent targeted therapy with biologic therapy is allowed. Pembrolizumab (or other immune checkpoint inhibitors), trastuzumab and/or pertuzumab, or bevacizumab are allowed.
  • * Participant must be \>= 18 years old.
  • * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
  • * Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
  • * Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
  • * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
  • * Participants must not have a history of skin or limb metastases.
  • * Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
  • * Participants must not have pre-existing clinical peripheral neuropathy from any cause.
  • * Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.
  • * Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SWOG Cancer Research Network,

Melissa K Accordino, PRINCIPAL_INVESTIGATOR, SWOG - Columbia University

Katherine Pennington, MD, PRINCIPAL_INVESTIGATOR, NRG - University of Washington

Study Record Dates

2031-08-30