Cryotherapy & Oxaliplatin

Not Applicable

Recruiting

• Conditions: Colon Cancer; Peripheral Neuropathy
• Interventions: Device: Cryotherapy Gloves

• Registration Number: NCT06281925
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Study Start: 2025-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy Gloves	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants with Peripheral Neuropathy at Visit 2	Visit 2 (Day 1)	Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 3	Visit 3 (Day 21)	Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 5	Visit 5 (Day 63)	Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 4	Visit 4 (Day 42)	Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States