Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
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Participants must have a diagnosis of a solid tumor malignancy.
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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.
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Participant must be >= 18 years old.
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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.
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Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
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Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
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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 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.
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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
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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