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Search / Trial NCT06281925

Cryotherapy & Oxaliplatin

Launched by NYU LANGONE HEALTH · Feb 21, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring whether cryotherapy, a treatment that involves applying extreme cold, can help prevent a common side effect called peripheral neuropathy in patients with stage III colon cancer who are starting chemotherapy with a drug called oxaliplatin. Peripheral neuropathy can cause tingling, pain, and numbness in the hands and feet, which can be quite uncomfortable for patients undergoing treatment.

To be eligible for this study, participants must be over 18, diagnosed with stage III colon cancer, and not have received chemotherapy before. They should also be planning to start a specific chemotherapy regimen called Capecitabine + Oxaliplatin (often shortened to CAPOX). However, individuals with certain conditions, such as diabetes or pre-existing nerve damage, cannot participate. If you join the trial, you’ll receive cryotherapy alongside your chemotherapy, and the study will help researchers learn more about how effective this approach can be in protecting against nerve damage during treatment.

Gender

ALL

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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Mineola, New York, United States

Patients applied

0 patients applied

Trial Officials

Sarah Mendez

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported