NCT06281925

Cryotherapy & Oxaliplatin

A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer
• Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Cryotherapy Gloves	All patients in the intervention group will receive cryotherapy with cold packs enclosed in a fabric envelope (gloves). The fabric envelope (gloves) will be patient specific.

Timeline

• Start date: 2025-03-13
• Primary completion: 2027-04-30
• Completion: 2027-06-30
• First posted: 2024-02-28
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study