This study is a randomized controlled trial of electroacupuncture (referred to as EA) versus sham acupuncture (referred to as EA) as effective treatments for Chemotherapy-Induced Peripheral Neuropathy (CIPN) pain in cancer survivors.

During the study, patients will be randomized to one of the two possible acupuncture treatment groups and receive 10 treatments over the course of 8 weeks and then enter a follow-up period. 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. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.

Inclusion Criteria:

• English-proficient men and women aged ≥18 years
• Free of oncologic 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 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 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 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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Ting Bao, MD at ting_bao@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Randomization will occur before the baseline assessments are administered. Each site will randomize its own patients through RedCap. Once the patient is randomized, the site acupuncture team will be notified via RedCap alert in order to provide the appropriate treatment. Patients and non-acupuncturist members of the study team will be blinded to which acupuncture group the patient was assigned. The acupuncturists and one clinical research coordinator will be the only ones unblinded. The clinical research coordinator will be unblinded in order to assist acupuncturists to confirm randomization. This clinical research coordinator will not be the primary research coordinator in the study and will not have direct contact with the patient. The rest of the study coinvestigators and staff will remain blinded.