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

NCT05642611 | Recruiting Phase 3 DMC

• 4 other identifiers: S2205NCI-2022-09251SWOG-S2205UG1CA189974
• Study Type: interventional
• Target: 777
• Locations: 1 country
• Sites: 36

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no)

  Defined as an absolute increase of 8 or more points over baseline in the CIPN-20 sensory neuropathy subscale score. Analysis will be conducted multivariable logistic regression, adjusting for the baseline score and the stratification factor as covariates.

  At the 12-week assessment after randomization

Secondary Outcomes (4)

• Mean sensory neuropathy scores

  At 12 weeks

• Dropouts

  Prior to the week 12 assessment

• Trajectories over time

  6, 12, 24, and 52 weeks

• Rates of adverse events

  At 12 weeks

Study Arms (3)

Arm 1 (Cryocompression)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Cryocompression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm 2 (Continuous Compression)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Pneumatic Compression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm 3 (Low Cyclic Compression)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen Collection; Procedure: Pneumatic Compression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood, plasma, and serum

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm 1 (Cryocompression); Arm 2 (Continuous Compression); Arm 3 (Low Cyclic Compression)

Cryocompression Therapy PROCEDURE

Undergo cryocompression

Arm 1 (Cryocompression)

Pneumatic Compression Therapy PROCEDURE

Undergo continuous compression

Arm 2 (Continuous Compression)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm 1 (Cryocompression); Arm 2 (Continuous Compression); Arm 3 (Low Cyclic Compression)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (Cryocompression); Arm 2 (Continuous Compression); Arm 3 (Low Cyclic Compression)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (36)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

SUSPENDED

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

RECRUITING

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652, United States

RECRUITING

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, 07450, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

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

New York, New York, 10032, United States

RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

ACTIVE NOT RECRUITING

CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States

RECRUITING

Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States

RECRUITING

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

RECRUITING

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

RECRUITING

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341, United States

RECRUITING

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

SMC Center for Hematology Oncology Union

Union, South Carolina, 29379, United States

RECRUITING

Regional Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37604, United States

RECRUITING

STCC at DHR Health Institute for Research and Development

Edinburg, Texas, 78539, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

SUSPENDED

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Melissa K Accordino

  SWOG - Columbia University

  PRINCIPAL INVESTIGATOR

• Katherine Pennington, MD

  NRG - University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine Trevino

CONTACT

210-614-8808; jtrevino@swog.org

Mariah Norman

CONTACT

210-614-8808; mnorman@swog.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: June 6, 2023
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 30, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (36)