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A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
NYU Langone Health
Mineola, New York, United States
NYU Langone Health
New York, New York, United States
Start Date
March 13, 2025
Primary Completion Date
April 30, 2027
Completion Date
June 30, 2027
Last Updated
March 6, 2026
40
ESTIMATED participants
Cryotherapy Gloves
DEVICE
Lead Sponsor
NYU Langone Health
NCT04704661
NCT04674267
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