Comparative Effectiveness of Acupuncture and Nonsteroidal Anti-inflammatory Drugs for the Management of Aromatase Inhibitor Induced Arthralgia Among Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Acupuncture can improve joint symptoms resulting from aromatase inhibitor and quality of life
研究概览
简要总结
Hormone therapy is used to treat women with hormone receptor-positive breast cancer and aromatase inhibitor (AI) is administered after menopause. AI therapy has been proven to be effective in improving the disease-free survival rate, decreasing the recurrence rates and a lower incidence of contralateral breast cancer. However, arthralgia frequently reported as an important adverse event of AI therapy and sometimes resulted in noncompliance with AI therapy. The prevalence of AI induced arthralgia rates ranged from 20 to 74%. Inadequately managed AI induced arthralgia remains a major unmet need in oncology practice in breast cancer survivors.
The goal of this project is to conduct a crossover designed pragmatic clinical trial to evaluate the effectiveness of acupuncture versus NSAID (Diclofenac) for the management of aromatase inhibitor induced arthralgia.
The third group was set to use non-steroidal analgesics plus acupuncture to evaluate the effectiveness of joint pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women who were postmenopausal aged more than 20 years old.
- •history of stage 0 to III hormone receptor-positive breast cancer, and currently taking a third-generation AI (anastrozole, letrozole, or exemestane) for at least 3 month.
- •Those who reported pain and/or stiffness in one or more joints, which started or worsened after initiation of AI therapy had worst joint pain rated at least three or greater on a 0-10 numerical rating scale in the preceding week.
排除标准
- •any prior acupuncture use for AI-induced joint symptoms or acupuncture within 1 months before entry
- •inflammatory, metabolic, or neuropathic arthropathies
- •bone fracture/surgery of an afflicted extremity during the preceding 6 months
- •allergy to NSAID
- •current use of narcotics
- •bleeding or coagulation disorders
- •localized skin infections
- •needle phobia
- •intra-articular corticosteroid within 4 weeks preceding the study
- •any severe chronic or uncontrolled comorbid disease
研究组 & 干预措施
Acupuncture to NSAIDs
干预措施: Diclofenac (Drug)
NSAIDs to Acupuncture
干预措施: Diclofenac (Drug)
Combined both acupuncture and NSAIDs
干预措施: Diclofenac (Drug)
结局指标
主要结局
Acupuncture can improve joint symptoms resulting from aromatase inhibitor and quality of life
时间窗: one year
Patients will be asked to complete a baseline questionnaire covering demographic information and reproductive history. At baseline and at 4, 6 and 10 weeks, self-administered questionnaires including the 10mm visual analogue scales. Follow-up assessments will be conducted at the 4 weeks after the end of intervention. According to statistically estimation, we compare the changes between three subgroups and hypothesize 20% difference as significant effect after intervention. We use ANOVA to calculate the sample size with an alpha of 0.05 as significance level, approximately 80% power and 20% drop-out rate. The trial will enroll 145 participants.
次要结局
未报告次要终点