Colon Cancer, Peripheral Neuropathy
Conditions
Brief 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.
Interventions
DEVICECryotherapy Gloves
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Mendez
NYU Langone Health
Outcome results
None listed