Effects of infrared laser moxibustion on cancer-related fatigue in breast cancer survivors: Study protocol for a randomized controlled trial.

BACKGROUND:Cancer-related fatigue (CRF) is the most common and distressing symptom associated with cancer treatment that breast cancer survivors (BCS) experience. We previously found that laser moxibustion may be efficacious for CRF. The primary aim of this study is to determine the specific efficacy of 10.6 μm infrared laser moxibustion on CRF. The secondary aim is to evaluate the effect of infrared laser moxibustion on co-existing symptoms that BCS experience. METHODS:We will conduct a randomized, sham-controlled, three-arm trial of infrared laser moxibustion (ILM) against sham ILM (SILM) and waitlist control (WLC) among BCS with moderate to severe fatigue. The two intervention groups will receive either real or sham infrared laser moxibustion on four acupoints (i.e., ST36 [bilateral], CV4, and CV6) for 20 minutes each session for 6 weeks (twice per week). The primary endpoint is the change in fatigue score from Baseline to Week 6 as measured by the Chinese version of the Brief Fatigue Inventory (BFI-C). Our secondary aim is to compare the severity of co-morbidities (e.g., depression, insomnia, and pain) among the 3 groups. DISCUSSION:The results of our trial will establish evidence for the efficacy of infrared laser moxibustion for CRF, a very common and challenging symptom. TRIAL REGISTRATION NUMBER:NCT03553355.