Cryotherapy & Oxaliplatin

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.

Study Overview

• Status: Suspended
• Conditions: Colon Cancer; Peripheral Neuropathy
• Intervention / Treatment: Device: Cryotherapy Gloves

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sarah Mendez, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: 22-01363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: sarah.mendez@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to sarah.mendez@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes