Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women With Breast or Gynecologic Cancers: Mechanisms of Action and Feasibility

This pilot feasibility study aims to determine if conducting a trial of AT for CIPN is feasible at Huntsman Cancer Institute (HCI). The investigators aim to enroll and retain twenty participants who will undergo fMRI during the baseline visit, receive 10 sessions of AT, and undergo fMRI after completion of AT. The investigators will examine fMRI for potential neurologic mechanisms of action of AT in CIPN management. The ultimate objective of this pilot project is to lay the foundation for a future randomized controlled clinical trial of AT for CIPN. Specifically, the investigators will be able to demonstrate that the investigators have the team and location in place to conduct a successful trial.

The participant will receive 10 acupuncture treatments over the course of 8 weeks with a baseline fMRI done prior to receiving acupuncture treatments and a final fMRI done after the completion of acupuncture treatments. Participant will receive questionnaires before fMRI, acupuncture treatments following final fMRI and at a 3 month follow up time point. (See below for more detail.)

1.1 Primary Objectives and Endpoints

To evaluate the feasibility to conduct a trial of AT for CIPN + standard of care therapy. Primary feasibility objectives will be evaluated in terms of recruitment (enrollment of 20 women, average of 2 eligible women per month to participate in the trial, identification of appropriate recruitment strategies, the appropriateness of eligibility criteria), retention (70% or more participants comply with 8 or more AT sessions and complete both fMRI scans), safety (zero serious adverse events directly related to AT) and questionnaire completion (70% or more enrolled participants comply with all data collection).

1.1.1 Primary outcome measures: Mean enrollment, completion rate of AT, fMRI, rate of serious adverse events, rate of questionnaire completion.