Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05642611

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

Led by SWOG Cancer Research Network · Updated on 2026-05-06

777

Participants Needed

36

Research Sites

429 weeks

Total Duration

On this page

Sponsors

S

SWOG Cancer Research Network

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.

Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 36 locations

1

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Contra Costa Regional Medical Center

Martinez, California, United States, 94553-3156

Suspended

3

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States, 06824

Actively Recruiting

4

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

5

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States, 06611

Actively Recruiting

6

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

7

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States, 96826

Actively Recruiting

8

University of Kansas Cancer Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

9

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States, 66211

Actively Recruiting

10

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States, 66205

Actively Recruiting

11

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

Actively Recruiting

12

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States, 48038

Actively Recruiting

13

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

14

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

15

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

16

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States, 07652

Actively Recruiting

17

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, United States, 07450

Actively Recruiting

18

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

19

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

New York, New York, United States, 10032

Actively Recruiting

20

State University of New York Upstate Medical University

Syracuse, New York, United States, 13210

Active, Not Recruiting

21

CaroMont Regional Medical Center

Gastonia, North Carolina, United States, 28054

Actively Recruiting

22

Cone Health Cancer Center

Greensboro, North Carolina, United States, 27403

Actively Recruiting

23

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States, 28791

Actively Recruiting

24

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States, 45220

Actively Recruiting

25

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

26

McLeod Regional Medical Center

Florence, South Carolina, United States, 29506

Actively Recruiting

27

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States, 29341

Actively Recruiting

28

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States, 29651

Actively Recruiting

29

Spartanburg Medical Center

Spartanburg, South Carolina, United States, 29303

Actively Recruiting

30

SMC Center for Hematology Oncology Union

Union, South Carolina, United States, 29379

Actively Recruiting

31

Regional Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, United States, 37604

Actively Recruiting

32

STCC at DHR Health Institute for Research and Development

Edinburg, Texas, United States, 78539

Actively Recruiting

33

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

34

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, United States, 23114

Actively Recruiting

35

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Suspended

36

University of Washington Medical Center - Montlake

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

J

Justine Trevino

CONTACT

M

Mariah Norman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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