NCT00081965已完成不适用
Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Frequency and severity of hot flashes, as measured by a hot flash diary
研究概览
简要总结
RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer
PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer.
Secondary
- Determine the long-term effects of acupuncture on hot flashes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of breast cancer (including in situ disease)
- •Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer Center (MSKCC) or its regional site (Commack)
- •Has an average of 3 or more hot flashes a day during 1 week of baseline diary recording
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Pre- or postmenopausal
- •Karnofsky performance status 70-100%
- •Ambulatory
- •No skin infection
- •PRIOR CONCURRENT THERAPY:
- •More than 3 weeks since prior and no concurrent treatment with any of the following during the 6 week evaluation period of the trial:
- •Initiation of a new chemotherapy regimen
- •Initiation of immunotherapy
- •Initiation of radiotherapy
- •Initiation or cessation of hormonal therapy
- •More than 6 weeks since prior acupuncture treatment (6 months for acupuncture specifically for the treatment of hot flashes)
- •No concurrent pharmacological treatment for hot flashes unless dose has been stable for 4 weeks
- •No concurrent selective serotonin reuptake inhibitors (SSRIs) unless dose has been stable for 4 weeks
排除标准
- 未提供
结局指标
主要结局
Frequency and severity of hot flashes, as measured by a hot flash diary
次要结局
未报告次要终点
研究者
研究点 (1)
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