Acupuncture for cancer-related fatigue in breast cancer survivors: the AcuBreast study, a pragmatic randomized clinical trial

ABSTRACT Background Effectiveness of acupuncture for cancer-related fatigue (CRF) in breast cancer survivors (BCS) remains inconsistent, warranting large pragmatic randomized controlled trials (RCTs). Methods The AcuBreast trial was a pragmatic, two-arm RCT comparing acupuncture plus usual care versus usual care alone. Inclusion criteria required CRF lasting 6 months post-treatment, written informed consent, and sufficient Norwegian proficiency. Exclusion criteria included conditions known to contribute to fatigue, ongoing acupuncture, pregnancy, and bleeding disorders. The acupuncture group received 10–12 treatments over 8–12 weeks alongside usual care. Control group, usual care only. The primary outcome was CRF measured by the Chalder Fatigue Questionnaire (CFQ14/11). Secondary outcomes included fatigue severity (FSS), adverse events, and quality-adjusted life years (QALYs). Results Of 221 randomized survivors (acupuncture n=112, control n=109; mean age 52.5 years [SD=8.9]), retention at 3 months was 106 versus 85, and at 6 months was 102 versus 83. At 3 months, CFQ14 scores were significantly lower in the acupuncture group (mean difference: −6.9, 95% CI: −8.8 to −4.9, p0.001), sustained at 6 months (−3.5, 95% CI: −5.5 to −1.6, p0.001). FSS scores were also significantly lower at 3 months (−4.2, 95% CI: −7.2 to −1.3, p=0.005) and 6 months (−4.2, 95% CI: −7.1 to −1.2, p=0.006). Adverse events were mild and self-limiting. Conclusions Acupuncture significantly reduces CRF in BCS with effect sizes exceeding minimal clinically important differences for both CFQ14/11 and FSS. Treatment is safe with only mild, transient adverse events. Trial registration ClinicalTrials.gov Identifier: NCT04418115.