Cryotherapy & Oxaliplatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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

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Colon Cancer Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cryotherapy Gloves

Intervention Type DEVICE

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.

Control

Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No