peripheral neuropathy

A Randomized Clinical Trial Assessing a Topical Cream in Comparison to Placebo in Cancer Survivor Patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy)

7 visits and up to 19 weeks

1. Participants:

Inclusion Criteria:

  • Adult cancer patients with painful sensory peripheral neuropathy resulting from prior treatment of cancer with taxanes or platins. A diagnosis of CIPN (Chemotherapy-Induced Peripheral Neuropathy) should be supported by a) onset of pain in hands or feet after exposure to taxanes or platins, b) presence of painful symptoms in a symmetrical stocking and/or glove distribution, AND c) painful symptoms accompanied by non painful symptoms (e.g. tingling/ pins and needles and numbness). Patients must have stopped their chemotherapy treatment for at least 24 weeks and have had CIPN (Chemotherapy-Induced Peripheral Neuropathy) pain for at least 24 weeks at the time of screening. 

Exclusion Criteria:

  • Patients with other neuropathic conditions resulting from another cause than chemotherapy (ie. diabetic neuropathy) or skin irritations or lesions on the hands or feet.

2. Randomization:

Participants will be randomly assigned to a treatment group or a placebo group.

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Overland Park, Kansas - (Kansas City area)

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