Acupuncture Trial

Investigator: Polly Niravath, MD

Study Coordinator: Alexys Brock

Status: Open Not Enrolling

ClinicalTrials.gov Number: N/A

Phone: 346.238.4814

Protocol Number: Pro00020813

Description

A single arm pilot study of 20 patients will be used to determine the feasibility of EA as a treatment for cancer survivors who have been treated with curative intent, but who have persistent CIPN for ?3 months after the cancer treatment is completed. The primary outcome is the number of patients who are able to complete 8 or more of the prescribed 10 treatments. “Feasibility,” for the purposes of this trial is defined as ?15 patients completing ?8 prescribed treatments. Secondary outcomes include worst pain score on the BPI-SF, and the composite FACT/GOG-Ntx score to measure quality of life. Exploratory outcomes include the IENF density seen on skin biopsy, as well as the change in serum inflammatory cytokines. The FDA approved acupuncture needles for use by licensed practitioners in 1996. We propose to enroll 20 patients in a small observational clinical study.
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