Study Stopped
Study paused to enrollment
Cryotherapy & Oxaliplatin
A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
March 6, 2026
March 1, 2026
2.1 years
February 21, 2024
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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)
Study Arms (2)
Cryotherapy
EXPERIMENTALPatients 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.
Control
NO INTERVENTIONPatients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NYU Langone Health
Mineola, New York, 11501, United States
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Mendez
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2024
First Posted
February 28, 2024
Study Start
March 13, 2025
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.