Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase-inhibitor-related Joint Symptoms in Breast Cancer Patients

Robust methods are needed to efficiently conduct large, multi-site, randomized, controlled clinical trials of acupuncture protocols. SWOG S1200 is a randomized, controlled sham- and waitlist-controlled trial of a standardized acupuncture protocol treating aromatase-inhibitor (AI)-associated arthralgias in early-stage breast-cancer patients (n=228). The primary objective of this study was to determine at six weeks whether true acupuncture administered twice weekly for six weeks, as compared to sham acupuncture or a waitlist control, caused a reduction in AI-associated joint pain as assessed by patient reports. The study was conducted at 11 institutions across the US. The true acupuncture protocol was developed by using a consensus-based process. Both the true acupuncture and the sham acupuncture protocols consisted of 12 sessions administered over 6 weeks, followed by 1 session per week for 6 weeks. The true acupuncture protocol used standardized protocol points, and standardized acupoints were tailored to a patient’s joint symptoms. The similarly standardized sham acupuncture protocol utilized superficial needling of non-acupoints. Standardized methods, including online and in-person training, study manuals, monthly phone calls, and remote quality-assurance monitoring throughout the study period, were developed to train and monitor acupuncturists. Similarly, the research staff received online and in-person training and monthly phone calls.