NCT00892268终止2 期
Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 68
- 主要终点
- Improvement in pain, as defined by the WOMAC global score at 6 weeks
研究概览
简要总结
RATIONALE: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It is not yet known whether acupuncture is more effective than standard therapy analgesics in decreasing joint pain caused by aromatase inhibitors.
PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works compared with medication in reducing pain in postmenopausal women with breast cancer and joint pain.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of acupuncture in reducing pain, defined by improvements in overall WOMAC score at 6 weeks, in post-menopausal women with breast cancer and aromatase inhibitor (AI)-associated arthralgia.
Secondary
- To identify biologic correlates to acupuncture efficacy in this specific syndrome of AI-associated pain.
- To evaluate the efficacy of acupuncture in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Improvement in pain, as defined by the WOMAC global score at 6 weeks
次要结局
- Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels
- Menopausal symptoms as defined by the FACT-ES
研究者
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