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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: SWOG Cancer Research Network · Participants: 777 · Started: Jun 6, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05642611

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham Cancer Center, Birmingham
ConnecticutSmilow Cancer Hospital Care Center-Fairfield, Fairfield
Yale University, New Haven
Smilow Cancer Hospital Care Center-Trumbull, Trumbull
GeorgiaEmory University Hospital/Winship Cancer Institute, Atlanta
HawaiiKapiolani Medical Center for Women and Children, Honolulu
KansasUniversity of Kansas Cancer Center, Kansas City
University of Kansas Hospital-Indian Creek Campus, Overland Park
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyBaptist Health Lexington, Lexington
MichiganHenry Ford Macomb Hospital-Clinton Township, Clinton Township
Henry Ford Hospital, Detroit
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
New HampshireDartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
New JerseyThe Valley Hospital - Luckow Pavilion, Paramus
Valley Health System Ridgewood Campus, Ridgewood
New MexicoUniversity of New Mexico Cancer Center, Albuquerque
New YorkNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York
North CarolinaCaroMont Regional Medical Center, Gastonia
Cone Health Cancer Center, Greensboro
Margaret R Pardee Memorial Hospital, Hendersonville
OhioGood Samaritan Hospital - Cincinnati, Cincinnati
Rhode IslandRhode Island Hospital, Providence
South CarolinaMcLeod Regional Medical Center, Florence
Gibbs Cancer Center-Gaffney, Gaffney
Gibbs Cancer Center-Pelham, Greer
Spartanburg Medical Center, Spartanburg
SMC Center for Hematology Oncology Union, Union
TennesseeRegional Cancer Center at Johnson City Medical Center, Johnson City
TexasSTCC at DHR Health Institute for Research and Development, Edinburg
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston
VirginiaBon Secours Saint Francis Medical Center, Midlothian
WashingtonUniversity of Washington Medical Center - Montlake, Seattle

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.