Cryotherapy & Oxaliplatin

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.

• Cryotherapy Gloves (Device): 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.

Primary outcomes

• Proportion of Participants with Peripheral Neuropathy at Visit 2 [Visit 2 (Day 1)]: Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
• Proportion of Participants with Peripheral Neuropathy at Visit 3 [Visit 3 (Day 21)]: Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
• Proportion of Participants with Peripheral Neuropathy at Visit 4 [Visit 4 (Day 42)]: Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
• Proportion of Participants with Peripheral Neuropathy at Visit 5 [Visit 5 (Day 63)]: Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.

Sex: All, ages: 18 Years to any

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

• Sarah Mendez, Principal investigator, NYU Langone Health