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Comparing cooling and compression methods to prevent nerve damage from chemotherapy

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

Phase 3 Interventional SWOG Cancer Research Network · NCT05642611

This study is testing three different ways to help prevent nerve damage from chemotherapy in cancer patients receiving taxane-based treatments to see which method works best.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment777 (estimated)
Ages18 Years and up
SexAll
SponsorSWOG Cancer Research Network Research network
Drugs / interventionsPembrolizumab, trastuzumab, pertuzumab, bevacizumab, chemotherapy
Locations36 sites (Birmingham, Alabama and 35 other locations)
Trial IDNCT05642611 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of a solid tumor malignancy who are about to start specific chemotherapy regimens.

Not a fit: Patients who are not starting taxane-based chemotherapy or have other underlying conditions affecting nerve function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of painful nerve damage in patients undergoing chemotherapy.

How similar studies have performed: Previous studies have shown promise in using cooling and compression techniques to mitigate chemotherapy side effects, but this specific approach is being tested for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Malignant Solid Neoplasm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.