Ice wraps may shield nerves from chemo pain
NCT ID NCT05642611
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 777 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
35 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Locations
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Baptist Health Lexington
RECRUITINGLexington, Kentucky, 40503, United States
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Bon Secours Saint Francis Medical Center
RECRUITINGMidlothian, Virginia, 23114, United States
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CaroMont Regional Medical Center
RECRUITINGGastonia, North Carolina, 28054, United States
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Cone Health Cancer Center
RECRUITINGGreensboro, North Carolina, 27403, United States
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Contra Costa Regional Medical Center
SUSPENDEDMartinez, California, 94553-3156, United States
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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Emory University Hospital/Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
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Fred Hutchinson Cancer Center
SUSPENDEDSeattle, Washington, 98109, United States
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Gibbs Cancer Center-Gaffney
RECRUITINGGaffney, South Carolina, 29341, United States
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Gibbs Cancer Center-Pelham
RECRUITINGGreer, South Carolina, 29651, United States
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Good Samaritan Hospital - Cincinnati
RECRUITINGCincinnati, Ohio, 45220, United States
Contact Email: •••••@•••••
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Henry Ford Hospital
RECRUITINGDetroit, Michigan, 48202, United States
Contact Email: •••••@•••••
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Henry Ford Macomb Hospital-Clinton Township
RECRUITINGClinton Township, Michigan, 48038, United States
Contact Email: •••••@•••••
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Kapiolani Medical Center for Women and Children
RECRUITINGHonolulu, Hawaii, 96826, United States
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Margaret R Pardee Memorial Hospital
RECRUITINGHendersonville, North Carolina, 28791, United States
Contact Email: •••••@•••••
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McLeod Regional Medical Center
RECRUITINGFlorence, South Carolina, 29506, United States
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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITINGNew York, New York, 10032, United States
Contact Email: •••••@•••••
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Regional Cancer Center at Johnson City Medical Center
RECRUITINGJohnson City, Tennessee, 37604, United States
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Rhode Island Hospital
RECRUITINGProvidence, Rhode Island, 02903, United States
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SMC Center for Hematology Oncology Union
RECRUITINGUnion, South Carolina, 29379, United States
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STCC at DHR Health Institute for Research and Development
RECRUITINGEdinburg, Texas, 78539, United States
Contact Email: •••••@•••••
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Smilow Cancer Hospital Care Center-Fairfield
RECRUITINGFairfield, Connecticut, 06824, United States
Contact Email: •••••@•••••
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Smilow Cancer Hospital Care Center-Trumbull
RECRUITINGTrumbull, Connecticut, 06611, United States
Contact Email: •••••@•••••
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Spartanburg Medical Center
RECRUITINGSpartanburg, South Carolina, 29303, United States
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State University of New York Upstate Medical University
ACTIVE_NOT_RECRUITINGSyracuse, New York, 13210, United States
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The Valley Hospital - Luckow Pavilion
RECRUITINGParamus, New Jersey, 07652, United States
Contact Email: •••••@•••••
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University of Alabama at Birmingham Cancer Center
RECRUITINGBirmingham, Alabama, 35233, United States
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University of Kansas Cancer Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kansas Hospital-Indian Creek Campus
RECRUITINGOverland Park, Kansas, 66211, United States
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University of Kansas Hospital-Westwood Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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University of New Mexico Cancer Center
RECRUITINGAlbuquerque, New Mexico, 87106, United States
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University of Washington Medical Center - Montlake
RECRUITINGSeattle, Washington, 98195, United States
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Valley Health System Ridgewood Campus
RECRUITINGRidgewood, New Jersey, 07450, United States
Contact Email: •••••@•••••
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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