NCT07137221

Acupuncture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome.

Acupunture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome: A Pilot Study (FLAIR: Flushes, Acupuncture, Inflammation Research)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, non-interventional, non-pharmacological study. In this study, postmenopausal patients with breast cancer in the adjuvant setting will be enrolled and treated with acupuncture to reduce hot flashes and other climacteric symptoms.

Detailed description

In healthy postmenopausal women, hot flashes (HF) have been associated with systemic inflammation. Several studies suggest that acupuncture (ACU) is effective in improving menopausal HF symptoms, both in healthy women and in patients with breast cancer. The effectiveness of ACU appears to be independent of changes in estradiol, FSH, and LH levels; however, the precise mechanisms through which ACU alleviates HF have not yet been clearly documented. Various studies indicate that menopause may trigger an increase in pro-inflammatory cytokines, likely due to the decline in sex hormone levels. Moreover, the elevated levels of pro-inflammatory factors during menopause may be linked to later health events, such as the development of osteoporosis and atherosclerosis. The literature highlights a connection between increased activity of pro-inflammatory cytokines-particularly IL-6-and postmenopausal bone loss, involving the RANK and Osteoprotegerin (OPG) pathways. The severity of HF is also significantly associated with the HOMA index and other markers of insulin resistance. This suggests a possible correlation between the severity of postmenopausal HF and the risk of cardiovascular disease, including in breast cancer patients. The primary objective of this study is to investigate the biochemical mechanisms underlying the effectiveness of acupuncture in alleviating hot flashes and other climacteric symptoms in postmenopausal women with breast cancer. Specifically, the study aims to determine whether the clinical benefits observed with acupuncture treatment are associated with measurable changes in inflammatory dysregulation in this patient population. In addition to the primary objective, the study includes several secondary aims. These involve evaluating the relationship between the improvement of postmenopausal symptoms and various biological markers, including indicators of bone loss, insulin resistance, hormone levels, and lipid profile. Furthermore, the study seeks to explore the correlation between circulating biomarkers and pain relief, as measured through validated instruments such as the EQ-5D-5L and BPI questionnaires, in the context of acupuncture treatment. It is anticipated that approximately 60 patients will participate, and the study will last a total of 42 months.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Post menopausal breast cancer patients	All selected patients will undergo peripheral blood samplingfor the evaluation of inflammatory biomarkers and must have agreed to store and use part of their sample for research purposes. A panel of inflammatory cytokines (IFNγ, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-22, TNFα) will be detected by ELISA assay. Other biomarkers such as RANKL, OPG, Vitamin D levels, CTX, PTH will be evaluated by immunoenzymatic assays. In addition, mirNAs as mir-16 and mir-378 will be evaluated by RT-PCR. Glucose metabolic markers such as fasting glucose and insulin, HbA1c and other parameters such as calcemia, PTH, c-telopeptide etc. will be collected. In particular, the evaluation of the biomarkers will be done on plasma samples at different time points (previously the administration of 10 course of weekly acupuncture; at the end and 6 months after the end of acupuncture and at the time of symptoms recurrence.

Timeline

• Start date: 2019-07-02
• Primary completion: 2020-12-30
• Completion: 2023-03-24
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: Italy