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Trial Title:
Cryotherapy & Oxaliplatin
NCT ID:
NCT06281925
Condition:
Colon Cancer
Peripheral Neuropathy
Conditions: Official terms:
Colonic Neoplasms
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Cryotherapy Gloves
Description:
All patients in the intervention group will receive cryotherapy with cold packs enclosed
in a fabric envelope (gloves). The fabric envelope (gloves) will be patient specific.
Arm group label:
Cryotherapy
Summary:
The primary objective of this study is to determine if cryotherapy is beneficial to
patients with colon cancer who are receiving oxaliplatin in the prevention of developing
chemotherapy induced peripheral neuropathy.
Detailed description:
Peripheral neuropathy often manifests as numbness and tingling in the hands and feet,
which may be detrimental to the patients' overall safety and quality of life, thereby
causing them to stop or delay treatment. Everyday tasks such as walking, buttoning a
shirt, or tying shoes can become challenging. Select chemotherapy agents are known to
cause significant peripheral neuropathy. Studies have been performed demonstrating
efficacy of using cryotherapy, which causes vasoconstriction, to targeted areas of the
body, in relation to paclitaxel. These studies have shown drastic differences between
those who receive cryotherapy during treatment and those who do not. There are few
studies on the use of cryotherapy in the prevention of peripheral neuropathy with the use
of oxaliplatin, which will be undertaken in this study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Over the age of 18 years
- Willingness to participate in research
- Diagnosed with stage III colon cancer
- Chemotherapy naïve
- Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part
of standard of care.
Exclusion Criteria:
- Pre-existing peripheral neuropathy
- Pre-existing diabetes
- Raynaud's disease
- Metabolic syndrome, including: Hypertension; Hypercholesterolemia; and Obesity (BSA
> 2)
- Upper extremity amputees
- Specific autoimmune diseases: Guillain-Barre; Lupus; Rheumatoid arthritis; and
Sjogren's syndrome
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NYU Langone Health
Address:
City:
Mineola
Zip:
11501
Country:
United States
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Start date:
September 30, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281925
