Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)
研究概览
简要总结
RATIONALE: Acupuncture may help relieve joint stiffness related to aromatase inhibitors in patients with early-stage breast cancer.
PURPOSE: This single arm clinical study aims to evaluate how well acupuncture as a non-pharmacological treatment, works in treating patients with joint stiffness related to aromatase inhibitors (AIs) in patients with early-stage breast cancer.
详细描述
Objectives of this study:
Primary objective:
To evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6.
Secondary objectives:
To evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of stage I-III breast cancer and free of disease by clinical examination
- •Postmenopausal or premenopausal with ovarian suppression
- •Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment
- •With joint stiffness attributed to the use of aromatase inhibitors
- •Having had joint stiffness for at least 1 months
- •Having had at least 15 days with stiffness in the preceding 30 days
排除标准
- •Women with recurrent or metastatic breast cancer
- •Women having finished chemotherapy or radiation therapy less than 1 months prior to enrollment
- •Women with history of bleeding disorder
- •Women with joint stiffness attributed to inflammatory arthritis, such as rheumatoid arthritis, spondy loarthritis and osteoarthritis
- •Women having joint stiffness prior to AI treatment
- •Women that have received treatment of any kind for joint stiffness within the last 3 months
- •Women that have previously received the acupuncture treatment before for any reason
结局指标
主要结局
The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)
时间窗: 6 weeks
The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) at the end of week 6 of intervention compared to that at baseline.
次要结局
- The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)(6 weeks)
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University