Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Relief from the hot flashes as determined by the hot flashes scoring system.
研究概览
简要总结
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks
详细描述
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks. Acupuncture was done according to specific guidelines and mapping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Treatment for prostate cancer using hormonal ablation therapy
- •Average of three or more hot flashes a day
- •Performance Status (Karnofsky ≥ 60)
- •Patients must be ≥ 18 years of age
- •No other clinically significant disease
- •Signed study-specific consent form prior to study entry
排除标准
- •Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study
- •Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks)
- •Skin infections
- •Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.
结局指标
主要结局
Relief from the hot flashes as determined by the hot flashes scoring system.
时间窗: 6 months
A Questionnaire was given to the patients to determine the relief of hot flashes
次要结局
未报告次要终点
研究者
Hani Ashamalla, MD
Chairman of Radiation Oncology Department
New York Presbyterian Brooklyn Methodist Hospital