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

Recruiting now · Phase 3

Conditions studied: Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT05642611

Run by

SWOG Cancer Research Network

People needed

777

Starts

2023-06-06

Expected to finish

2031-08-30

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations.

You may not qualify if…

• 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.

Where it is running

• University of Washington Medical Center - Montlake — Seattle, Washington, United States (enrolling)
• Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States (enrolling)
• Bon Secours Saint Francis Medical Center — Midlothian, Virginia, United States (enrolling)
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (enrolling)
• Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States (enrolling)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (enrolling)
• University of Kansas Cancer Center — Kansas City, Kansas, United States (enrolling)
• University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States (enrolling)
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States (enrolling)
• Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
• Henry Ford Macomb Hospital-Clinton Township — Clinton Township, Michigan, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States (enrolling)
• Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States (enrolling)
• The Valley Hospital - Luckow Pavilion — Paramus, New Jersey, United States (enrolling)
• Valley Health System Ridgewood Campus — Ridgewood, New Jersey, United States (enrolling)
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States (enrolling)
• NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States (enrolling)
• CaroMont Regional Medical Center — Gastonia, North Carolina, United States (enrolling)
• Cone Health Cancer Center — Greensboro, North Carolina, United States (enrolling)
• Margaret R Pardee Memorial Hospital — Hendersonville, North Carolina, United States (enrolling)
• Good Samaritan Hospital - Cincinnati — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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