Investigating biochemical markers of Acupuncture's effectiveness in managing climacteric syndrome in breast cancer patients: the FLAIR study

Background: Breast cancer (BC) remains a global health issue, with most women receiving adjuvant hormone therapy. Hot flushes and climacteric symptoms often compromise treatment adherence. Acupuncture has shown promise in alleviating these symptoms and improving quality of life (QoL). This prospective study aimed to investigate the mechanisms underlying acupuncture's effects on menopausal symptoms in breast cancer patients receiving endocrine therapy, with a secondary focus on inflammatory biomarker changes. Methods: This open-label biological study enrolled 37 early BC patients receiving endocrine treatment, and acupuncture treatment provided at IRST within the integrative care pathway, of whom 27 completed all evaluations. Participants underwent a 10-session weekly acupuncture program based on Traditional Chinese Medicine, using fixed points (SP6, CV4, LI11, BL11, GB39). Blood samples for biochemical and cytokine analysis (IL-5, IL-6, IL-10, IL-8, IL-22, TNFα) were collected at baseline (T0), post-treatment (T1), and six months later (T2) during regular clinical and laboratory workups. Clinical outcomes were assessed using the Green Climacteric Scale (GCS), EQ-5D-5L, and Brief Pain Inventory (BPI). The study followed STRICTA guidelines. Results: Acupuncture significantly improved vasomotor and climacteric symptoms, with reduced GCS and hot flash scores at T1 and T2 (p < 0.0001). QoL and pain scores also significantly improved at both time points. Among the cytokines measured over time, a significant reduction in TNFα levels was observed (p = 0.006), though no correlation emerged between cytokine changes and clinical outcomes. Conclusions: Acupuncture proved effective in improving menopausal symptoms and QoL in BC patients receiving endocrine therapy. The modulation of TNFα suggests a potential biological role in the mechanism of symptom relief.