Colon Cancer Clinical Trial

Cryotherapy & Oxaliplatin

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.

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Full 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.

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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

Study is for people with:

Colon Cancer

Estimated Enrollment:

40

Study ID:

NCT06281925

Recruitment Status:

Not yet recruiting

Sponsor:

NYU Langone Health

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There are 2 Locations for this study

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NYU Langone Health
Mineola New York, 11501, United States
NYU Langone Health
New York New York, 10016, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

40

Study ID:

NCT06281925

Recruitment Status:

Not yet recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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