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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
NYU Langone Health
Mineola, New York, United States
NYU Langone Health
New York, New York, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 5 (Day 63)
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