RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-06
Study Completion:2031-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05642611

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have a diagnosis of a solid tumor malignancy.
  2. * 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.
  3. * Weekly paclitaxel x 12 consecutive weeks
  4. * Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
  5. * Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
  6. * 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.
  7. * Participant must be \>= 18 years old.
  8. * 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.
  9. * Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
  10. * Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
  11. * 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.
  1. * Participants must not have a history of skin or limb metastases.
  2. * Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
  3. * Participants must not have pre-existing clinical peripheral neuropathy from any cause.
  4. * Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.
  5. * Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.

Contacts and Locations

Study Contact

Justine Trevino
CONTACT
210-614-8808
jtrevino@swog.org
Mariah Norman
CONTACT
210-614-8808
mnorman@swog.org

Principal Investigator

Melissa K Accordino
PRINCIPAL_INVESTIGATOR
SWOG - Columbia University
Katherine Pennington, MD
PRINCIPAL_INVESTIGATOR
NRG - University of Washington

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, 07450
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403
United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
McLeod Regional Medical Center
Florence, South Carolina, 29506
United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

  • Melissa K Accordino, PRINCIPAL_INVESTIGATOR, SWOG - Columbia University
  • Katherine Pennington, MD, PRINCIPAL_INVESTIGATOR, NRG - University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06
Study Completion Date2031-08-30

Study Record Updates

Study Start Date2023-06-06
Study Completion Date2031-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Solid Neoplasm