A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
New York
NYU Langone Health
RECRUITING
Mineola
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Sarah Mendez
Sarah.mendez@nyulangone.org
347-835-7771
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 40
Treatments
Experimental: Cryotherapy
Patients receiving oxaliplatin who are randomized to the Interventional (Cryotherapy) Arm will wear a pair of gloves that has removable ice packs throughout their treatment, starting 15 minutes before and ending 15 minutes after completion of oxaliplatin. These ice packs will be replaced every 30 minutes. The total wearing time of the cryotherapy will be approximately 2 hours.
No_intervention: Control
Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health