Acupunture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome: A Pilot Study (FLAIR: Flushes, Acupuncture, Inflammation Research)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Acupuncture Effects on Inflammation and Menopausal Symptoms in Breast Cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a previous diagnosis of breast cancer.
- •Not metastatic disease
- •Disorders of thermoregulation with or without any other symptoms referable to the syndrome menopausal or perimenopausal from at least 6-8 weeks prior study entry
- •Age 18-65 years
- •patients with postmenopausal breast cancer defined as follows:
- •bilateral oophorectomy
- •age ≥ 60 years
- •age ≤ 60 years, who has had at least 12 consecutive months of amenorrhea in the absence of any adjuvant treatment and serum dosage of FSH and E2 in the postmenopausal range (FSH> 40IU/L and E2 <10 pg/ml)
- •age <60 years, treated with tamoxifen or aromatase inhibitors and serum dosage of FSH and E2 in the postmenopausal range (FSH> 40UI/L and E2 <10 pg/ml)
- •patients treated with GhRh analogues for at least 3 months in combination with tamoxifen or aromatase inhibitors for at least 2 months .- Early Postmenopause stage (≤ 5 years) based on Stages of Reproductive Aging Workshop (STRAW) criteria
- •BMI within the range of ≥18.5 Kg/m² and less than 24.5 kg/m²
- •Number of hot flushes greater than or equal to an average of 6/day in the week and / or average daily score on the climacteric scale of Greene> of 15 prior to enrolled in study
- •ECOG performance status < or equal to 1
- •Not previous diagnosis of inflammatory disorders such as rheumatic, respiratory, dermatologic, no gastroenterologic acute and chronic diseases; none immunological altered condition; no type 1 and 2 diabetes, hypertension, hyperlipidemia; no thyroid diseases or neurodegenerative diseases;
- •not women smokers
- •not concomitant homeopaty or phytotherapy treatment, corticosteroid, NSAID, antidepressant drugs
- •written informed consent
排除标准
- •Age < 18 or > 65 years
- •Metastatic breast cancer
- •Previous diagnosis of inflammatory disorders such as rheumatic, respiratory, dermatologic, gastroenterologic acute and chronic diseases; any immunological altered condition; type 1 and 2 diabetes; uncontrolled hypertension; hyperlipidemia in treatment; autoimmune thyroid diseases; neurodegenerative diseases;
- •Concomitant homeopathy or phytotherapy treatment, corticosteroid, NSAID, antidepressant drugs
- •Language or educational barriers to understanding the study purpose
结局指标
主要结局
Acupuncture Effects on Inflammation and Menopausal Symptoms in Breast Cancer
时间窗: 42 months
Change in Greene Climacteric Scale evaluated before (T0) and after treatment (ten weeks of treatment (T1) and six-month follow-up (T2)). The scale assigns a rating to the disruption caused by each symptom, ranging from 0 (undisturbed) to 3 (extremely disturbed), across three symptom categories: psychological, physical, and vasomotor. These categories are defined by 21 items, with a total score that ranges from 0 to 63. The mean value of menopausal symptoms experienced over seven consecutive days will be calculated, and changes observed between baseline (T0) and after ten weeks of treatment (T1) and six-month follow-up (T2) will be documented.
次要结局
- Correlation Between Symptom Improvement and Metabolic Markers in Postmenopausal Women.(42 months)
- Correlation of Biomarkers with Pain Relief and Acupuncture(42 months)