Ice wraps may shield nerves from chemo pain

NCT ID NCT05642611

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether cooling and compressing the arms and legs during taxane chemotherapy can prevent peripheral neuropathy—a common side effect causing numbness, tingling, or pain. About 777 cancer patients will be randomly assigned to one of three approaches: cryocompression (cooling + compression), continuous compression, or low cyclic compression. The goal is to see which method best prevents nerve damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryocompression therapy (cooling and compression of limbs)
What this could lead to
If it works, this could give cancer patients a simple, non-drug way to prevent painful nerve damage from taxane chemotherapy.
What could go wrong
This is a large phase III trial, but it's still possible that none of the compression methods work better than the others, or that the devices are too uncomfortable for patients to use consistently.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 777 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    35 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Health Lexington

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Bon Secours Saint Francis Medical Center

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • CaroMont Regional Medical Center

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • Cone Health Cancer Center

    RECRUITING

    Greensboro, North Carolina, 27403, United States

  • Contra Costa Regional Medical Center

    SUSPENDED

    Martinez, California, 94553-3156, United States

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fred Hutchinson Cancer Center

    SUSPENDED

    Seattle, Washington, 98109, United States

  • Gibbs Cancer Center-Gaffney

    RECRUITING

    Gaffney, South Carolina, 29341, United States

  • Gibbs Cancer Center-Pelham

    RECRUITING

    Greer, South Carolina, 29651, United States

  • Good Samaritan Hospital - Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45220, United States

    Contact Email: •••••@•••••

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Henry Ford Macomb Hospital-Clinton Township

    RECRUITING

    Clinton Township, Michigan, 48038, United States

    Contact Email: •••••@•••••

  • Kapiolani Medical Center for Women and Children

    RECRUITING

    Honolulu, Hawaii, 96826, United States

  • Margaret R Pardee Memorial Hospital

    RECRUITING

    Hendersonville, North Carolina, 28791, United States

    Contact Email: •••••@•••••

  • McLeod Regional Medical Center

    RECRUITING

    Florence, South Carolina, 29506, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Regional Cancer Center at Johnson City Medical Center

    RECRUITING

    Johnson City, Tennessee, 37604, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • SMC Center for Hematology Oncology Union

    RECRUITING

    Union, South Carolina, 29379, United States

  • STCC at DHR Health Institute for Research and Development

    RECRUITING

    Edinburg, Texas, 78539, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center-Fairfield

    RECRUITING

    Fairfield, Connecticut, 06824, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center-Trumbull

    RECRUITING

    Trumbull, Connecticut, 06611, United States

    Contact Email: •••••@•••••

  • Spartanburg Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • State University of New York Upstate Medical University

    ACTIVE_NOT_RECRUITING

    Syracuse, New York, 13210, United States

  • The Valley Hospital - Luckow Pavilion

    RECRUITING

    Paramus, New Jersey, 07652, United States

    Contact Email: •••••@•••••

  • University of Alabama at Birmingham Cancer Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Hospital-Indian Creek Campus

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of Washington Medical Center - Montlake

    RECRUITING

    Seattle, Washington, 98195, United States

  • Valley Health System Ridgewood Campus

    RECRUITING

    Ridgewood, New Jersey, 07450, United States

    Contact Email: •••••@•••••

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

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