Cryotherapy & Oxaliplatin

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281925
• Other study ID #: 22-01363
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Sarah Mendez
• Phone: 347-835-7771
• Email: Sarah.mendez[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	Mineola	New York
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)