Recruiting

Phase 3

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

Sponsor:

SWOG Cancer Research Network

Code:

NCT05642611

Conditions

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cryocompression Therapy

Pneumatic Compression Therapy

Quality-of-Life Assessment

Study Details

Brief summary:

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.

Conditions

Malignant Solid Neoplasm

Study ID

NCT05642611

Start date

Jun 6, 2023

Status verified date

Apr, 2026

Completion date

Aug 30, 2031

Anticipated

Primary completion date

Aug 1, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

777 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm 1 (Cryocompression)

Patients undergo cryocompression (cooling plus moderate and low pressure to the arms and legs) for 30-minutes pre-taxane chemotherapy infusion, during taxane chemotherapy infusion, and for 30 minutes after completion of each taxane infusion. Patients may also undergo collection of blood, serum and plasma samples during screening and on study.

experimental: Arm 2 (Continuous Compression)

Patients undergo continuous compression (moderate, steady pressure to the arms and legs) for 30-minutes pre-taxane chemotherapy infusion, during taxane chemotherapy infusion, and for 30 minutes after completion of each taxane infusion. Patients may also undergo collection of blood, serum and plasma samples during screening and on study.

active comparator: Arm 3 (Low Cyclic Compression)

Patients undergo low cyclic compression (low pressure that comes and goes to the arms and legs) for 30-minutes pre-taxane chemotherapy infusion, during taxane chemotherapy infusion, and for 30 minutes after completion of each taxane infusion. Patients may also undergo collection of blood, serum and plasma samples during screening and on study.

Interventions

Biospecimen Collection

Undergo collection of blood, plasma, and serum

Cryocompression Therapy

Undergo cryocompression

Pneumatic Compression Therapy

Undergo continuous compression

Pneumatic Compression Therapy

Undergo low cyclic compression

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no) [ Time Frame: At the 12-week assessment after randomization ]

Central Contacts and Locations

Central contacts

Justine Trevino

210-614-8808 jtrevino@swog.org

Mariah Norman

210-614-8808 mnorman@swog.org

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Nusrat Jahan

Smilow Cancer Hospital Care Center-Fairfield

Recruiting

Fairfield, Connecticut, United States, 06824

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Maryam B. Lustberg

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Maryam B. Lustberg

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Maryam B. Lustberg

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Demetria Smith-Graziani

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Christa Braun-Inglis

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671 KUCC_Navigation@kumc.edu

Principal Investigator:

Lauren Nye

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Site Public Contact

913-588-3671 KUCC_Navigation@kumc.edu

Principal Investigator:

Lauren Nye

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671 KUCC_Navigation@kumc.edu

Principal Investigator:

Lauren Nye

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Site Public Contact

859-260-6425

Principal Investigator:

Arvinda Padmanabhan

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Dawn M. Severson

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Dawn M. Severson

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230 crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Site Public Contact

800-639-6918 cancer.research.nurse@dartmouth.edu

Principal Investigator:

Elaine P. Kuhn

The Valley Hospital - Luckow Pavilion

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Site Public Contact

201-634-5792 clinicaltrialsresearch@valleyhealth.com

Principal Investigator:

Eleonora Teplinsky

Valley Health System Ridgewood Campus

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Site Public Contact

201-634-5792 clinicaltrialsresearch@valleyhealth.com

Principal Investigator:

Eleonora Teplinsky

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348 HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Bernard Tawfik

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

Recruiting

New York, New York, United States, 10032

Contacts

Site Public Contact

212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Melissa K. Accordino

CaroMont Regional Medical Center

Recruiting

Gastonia, North Carolina, United States, 28054

Contacts

Site Public Contact

704-834-2810 tammy.cozad@caromonthealth.org

Principal Investigator:

Bolanle Gbadamosi

Cone Health Cancer Center

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Site Public Contact

336-832-0836 stacey.phelps@conehealth.com

Principal Investigator:

Vinay K. Gudena

Margaret R Pardee Memorial Hospital

Recruiting

Hendersonville, North Carolina, United States, 28791

Contacts

Site Public Contact

828-696-4716 pardeecancerresearch@unchealth.unc.edu

Principal Investigator:

John K. Hill

Good Samaritan Hospital - Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Site Public Contact

720-874-1881 ResearchInstituteInquiries@CommonSpirit.org

Principal Investigator:

Shahzad Siddique

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Stephanie L. Graff

McLeod Regional Medical Center

Recruiting

Florence, South Carolina, United States, 29506

Contacts

Site Public Contact

843-777-0770 dorie.sturgill@mcleodhealth.org

Principal Investigator:

Rajesh Bajaj

Gibbs Cancer Center-Gaffney

Recruiting

Gaffney, South Carolina, United States, 29341

Contacts

Site Public Contact

864-560-6104 kmertz-rivera@gibbscc.org

Principal Investigator:

Isaac Alwine

Gibbs Cancer Center-Pelham

Recruiting

Greer, South Carolina, United States, 29651

Contacts

Site Public Contact

864-560-6104 kmertz-rivera@gibbscc.org

Principal Investigator:

Isaac Alwine

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Site Public Contact

864-560-6104 kmertz-rivera@gibbscc.org

Principal Investigator:

Isaac Alwine

SMC Center for Hematology Oncology Union

Recruiting

Union, South Carolina, United States, 29379

Contacts

Site Public Contact

864-560-6104 kmertz-rivera@gibbscc.org

Principal Investigator:

Isaac Alwine

Regional Cancer Center at Johnson City Medical Center

Recruiting

Johnson City, Tennessee, United States, 37604

Contacts

Site Public Contact

423-431-5654 charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

STCC at DHR Health Institute for Research and Development

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Site Public Contact

956-362-2390 dhrresearch@dhr-rgv.com

Principal Investigator:

Jose Cruz

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354 burton@bcm.edu

Principal Investigator:

Julie R. Nangia

Bon Secours Saint Francis Medical Center

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Site Public Contact

804-893-8978 anne_carmellat@bshsi.org

Principal Investigator:

William J. Irvin

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Renata Urban

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-05-06.