An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Trial Status: active
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.
Inclusion Criteria
English-proficient men and women aged >= 18 years
Free of oncologic disease or stable disease by clinical examination and history
Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment
Diagnosis of chemotherapy-induced peripheral neuropathy (CIPN) based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia
Grade >= 1 sensory pain based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the Brief Pain Inventory-Short Form (BPI-SF) average pain item over the past week
On a stable regimen (no change in the past three months) if taking anti-neuropathy or other pain medications
Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period
Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
Exclusion Criteria
Patients with a pacemaker or other electronically charged medical device
Use of acupuncture for symptom management within the past 12 months
Additional locations may be listed on ClinicalTrials.gov for NCT04917796.
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
