Using cryotherapy to prevent nerve damage in colon cancer patients receiving oxaliplatin
A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
This study is testing if using cold therapy gloves during chemotherapy can help prevent nerve damage in colon cancer patients receiving oxaliplatin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (Mineola, New York and 1 other locations) |
| Trial ID | NCT06281925 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of cryotherapy in preventing chemotherapy-induced peripheral neuropathy in patients with stage III colon cancer undergoing treatment with oxaliplatin. Participants will receive cryotherapy gloves during their chemotherapy sessions to potentially reduce the risk of developing nerve damage, which can significantly impact their quality of life and treatment adherence. The study builds on previous research that demonstrated the benefits of cryotherapy in similar contexts, particularly with other chemotherapy agents like paclitaxel. By focusing on a specific chemotherapy regimen, this trial seeks to fill a gap in existing literature regarding the use of cryotherapy with oxaliplatin.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with stage III colon cancer and are about to start a CAPOX chemotherapy regimen.
Not a fit: Patients with pre-existing peripheral neuropathy or certain metabolic and autoimmune conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for colon cancer patients by reducing the incidence of painful peripheral neuropathy.
How similar studies have performed: Previous studies have shown success with cryotherapy in preventing peripheral neuropathy in patients receiving other chemotherapy agents, but this specific application with oxaliplatin is less explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mineola, New York and 1 other locations
- NYU Langone Health — Mineola, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Mendez — NYU Langone Health
- Study coordinator: Sarah Mendez
- Email: Sarah.mendez@nyulangone.org
- Phone: 347-835-7771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.