Comparing cooling and compression methods to prevent nerve damage from chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates three different approaches to prevent chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving taxane-based chemotherapy. Participants will be randomized to receive either cryocompression therapy, continuous compression therapy, or low cyclic compression therapy using the Paxman Limb Cryocompression System. The study aims to determine which method is most effective in reducing the incidence of CIPN over a 12-week period, with secondary objectives assessing sensory and motor function over time. Adverse events related to the device will also be monitored to ensure safety.

Why it matters

Who can join: the full rules

Inclusion 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.

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.

Exclusion Criteria:

* 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's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• Smilow Cancer Hospital Care Center-Fairfield
  Fairfield, Connecticut, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Smilow Cancer Hospital Care Center-Trumbull
  Trumbull, Connecticut, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Kapiolani Medical Center for Women and Children
  Honolulu, Hawaii, United States Recruiting

Study contacts

• Principal investigator: Melissa K Accordino — SWOG - Columbia University
• Study coordinator: Justine Trevino
• Email: jtrevino@swog.org
• Phone: 210-614-8808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.