Objective: To evaluate the effect of laser auriculotherapy on health-related quality of life, cancer-related fatigue, and anxiety in women with advanced breast cancer undergoing palliative chemotherapy. Method: A randomized, parallel, single-blind, single-center clinical trial was conducted in a Brazilian oncology referral hospital. A total of 123 women were randomly divided into groups: 41 in the experimental group (10 weekly laser auriculotherapy sessions), 40 in the sham group (10 weekly sham sessions), and 42 in the control group. Outcomes were assessed at baseline, 5th week, and 11th week, using the Quality of Life Questionnaire Core-30, Functional Assessment of Cancer Therapy: Fatigue and State-Trait Anxiety Inventory. Statistical analyses included Kruskal–Wallis, Mann–Whitney, and Friedman tests. Results: The experimental group exhibited the highest mean overall quality of life, with a significant increase (p < 0.000001) between the second and third evaluations and a significant improvement in fatigue between the second and third evaluations (p = 0.00001). Conversely, women in the sham and control groups experienced a decline and worsening in both their quality of life and fatigue. Women in all three groups showed reduction an anxiety. Changes in anxiety in these women were not statistically significant. Conclusions: reduction improvement in health-related quality of life and a reduction in cancer-related fatigue in the experimental group. These results show a positive effect of auriculotherapy on cancer-related fatigue, demonstrating potential for application in clinical practice in women with advanced breast cancer and in palliative chemotherapy. Brazilian Registry of Clinical Trials: RBR-6hxffx4.
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