This phase III trial compares the effect of electroacupuncture to sham acupuncture for the treatment of nerve pain caused by chemotherapy-induced peripheral neuropathy. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. Electroacupuncture involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Electroacupuncture can increase the effects of regular acupuncture and may be effective in treating chemotherapy-induced peripheral neuropathy pain.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04917796.
PRIMARY OBJECTIVE:
I. To determine the efficacy of an eight-week electroacupuncture (EA) treatment on chemotherapy-induced peripheral neuropathy pain (CIPN) symptoms among cancer survivors with moderate to severe CIPN pain.
SECONDARY OBJECTIVE:
I. To evaluate the effect of EA versus (vs.) sham acupuncture (SA) on small sensory fiber function.
TERTIARY OBJECTIVE:
I. To evaluate whether baseline Quantitative Sensory Testing (QST) outcomes predict response to EA.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive 10 electroacupuncture treatments over 8 weeks.
GROUP II: Patients receive 10 sham acupuncture treatments over 8 weeks. After week 24 assessment, patients may receive 10 electroacupuncture treatments over 8 weeks.
After completion of study treatment, patients are followed up for 24 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorTing Bao
