Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults over 18 with stage III colon cancer who haven't started chemotherapy yet. They'll be starting a standard chemo treatment called CAPOX. People can't join if they already have nerve damage, diabetes, Raynaud's disease, metabolic syndrome (including high blood pressure and cholesterol), missing upper limbs, or certain autoimmune diseases.Inclusion Criteria
Willingness to participate in research
I have not received chemotherapy before.
I am starting CAPOX chemotherapy soon.
+2 more
Exclusion Criteria
I have diabetes.
I have nerve damage in my hands or feet.
I have Raynaud's disease.
+3 more
Participant Groups
The study is testing if wearing cryotherapy gloves helps prevent nerve damage in the hands caused by oxaliplatin, a drug used in chemotherapy for colon cancer patients.
2Treatment groups
Experimental Treatment
Active Control
Group I: CryotherapyExperimental Treatment1 Intervention
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 II: ControlActive Control1 Intervention
Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.
Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:
🇪🇺 Approved in European Union as Eloxatin for:
- Colorectal cancer
🇺🇸 Approved in United States as Eloxatin for:
- Colorectal cancer
🇨🇦 Approved in Canada as Eloxatin for:
- Colorectal cancer
🇯🇵 Approved in Japan as Eloxatin for:
- Colorectal cancer
🇨🇭 Approved in Switzerland as Eloxatin for:
- Colorectal cancer
🇨🇳 Approved in China as Ai Heng for:
- Colorectal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthMineola, NY
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor