peripheral neuropathy

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

  • Primary objective: Assess the efficacy and safety of a topical cream in cancer survivor adult patients with CIPN
  • 4 in person visits over the course of 13 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 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 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.

  1. Randomization:
  • Participants will be randomly assigned to a treatment group or a placebo group.

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Location

Overland Park, Kansas - (Kansas City area)

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