Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 5
- 主要终点
- Greene climacteric scale
研究概览
简要总结
The purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care).
详细描述
The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: Greene climacteric scale score, quality of life (MenQol italian version), overall improvement in climacteric syndrome, adverse effects from treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •breast cancer
- •thermoregulation symptoms from at least 6-8 weeks - at least 6 hot flushes a day
- •climateric simptoms
- •age from 18 to 65 years
- •spontaneous or caused by chemotherapy amenorrea
- •hormone therapy for breast cancer
- •Green climateric scale score = or > of 15
- •performance status Eastern Cooperative Oncology Group (ECOG) < or = to 1
- •the patient agrees to follow physical exercice
- •diet and self-help groups
排除标准
- •Hormone substitutive Therapy (TOS) during the last month
- •other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy)
- •chemotherapy or radiotherapy
- •patients who refuses acupuncture
结局指标
主要结局
Greene climacteric scale
时间窗: baseline ( 14 days before randomization) , between the 5th and 6th session af acupunture(only for experimental arm) at 14 weeks after randomization and at 3 and at 6 month after randomization for both arms.
Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.
次要结局
未报告次要终点