This phase II trial tests how well cryotherapy, use of cold packs, works in preventing chemotherapy-induced numbness, tingling, and pain in hands and feet (peripheral neuropathy) from developing in patients with stage III colon cancer receiving oxaliplatin. Oxaliplatin is a chemotherapy drug whose side effect profile includes peripheral neuropathy. Peripheral neuropathy can affect activities of daily living (ADL), both instrumental (such as preparing a meal, going grocery shopping, using a telephone) and self-care. Giving cryotherapy may work better in preventing chemotherapy-related peripheral neuropathy in patients with stage III colon cancer receiving oxaliplatin.
Additional locations may be listed on ClinicalTrials.gov for NCT06281925.
Locations matching your search criteria
United States
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU LangoneStatus: Active
Contact: Sarah Mendez
Phone: 212-731-5790
PRIMARY OBJECTIVE:
I. To determine if cryotherapy is beneficial to patients receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.
EXPLORATORY OBJECTIVE:
I. To summarize patients’ cold tolerance (CT) visual analogue scale (VAS) scores at every time-point the gloves are changed and explore any patterns among patients and between patients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients wear gloves with cold pack inserts over 2 hours beginning 15 minutes before and 15 minutes after each completion of standard of care (SOC) oxaliplatin intravenously (IV) over 3 hours on day 1 of each cycle. Cycles repeat every 2 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients receive SOC oxaliplatin IV over 3 hours on day 1 of each cycle. Cycles repeat every 2 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 months.
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorSarah Mendez
