Pilot Study on the Effect of Acupuncture on Joint Pain Induced by Aromatase Inhibitors in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Joint Pain
研究概览
简要总结
This is a randomized, controlled, pilot study to determine the safety and efficacy of acupuncture as an adjunct to pharmacological treatment compared to pharmacological intervention alone for the treatment of musculoskeletal pain related to aromatase inhibitors (AI) in postmenopausal breast cancer patients. Twenty participants (20 in each arm) will be enrolled at the Breast Oncology clinic at Columbia University Medical Center (CUMC). Patients in the treatment arm will receive acupuncture administered twice weekly for six weeks and will be allowed to take pain medication as necessary. The control patients will initially receive pain medication alone, then will cross-over to the acupuncture arm after six weeks. The investigators hypothesize that acupuncture will reduce AI induced joint symptoms.
The study will enroll a total of 40 patients, half of whom will be randomized to one of the two arms to receive acupuncture plus pharmacological treatment (arm A) or pharmacological treatment alone (arm B). Joint pain will be assessed by the BPI-SF score at baseline and six weeks. All patients will have a baseline BPI worst pain item (#2) ≥3 points on a scale of 0-10.
详细描述
The purpose of this study is to determine the safety and efficacy of acupuncture as a complementary therapy to pain medication for joint pain associated with aromatase inhibitors for breast cancer treatment. Breast cancer patients are living longer largely due to the benefits of hormonal therapy. Aromatase inhibitors (AIs) are a new class of hormonal agents which block estrogen synthesis in postmenopausal women. However, musculoskeletal pain occurs in up to 50% of patients treated with AIs and often does not respond to conventional pain medications. AI-induced joint pain interferes with patient compliance and may cause major disability. Therefore, safe and effective treatments are needed to alleviate AI-induced musculoskeletal pain.
Acupuncture is a traditional Chinese method of medical treatment and a popular modality for treating musculoskeletal pain. Acupuncture involves the use of thin needles to stimulate specific points of the body and leads to pain control through the release of endorphin in the central nervous system. Clinical trials have found a benefit of acupuncture for the treatment of knee and back pain. Given the lack of effective treatments for AI-induced joint pain and the safety and efficacy of acupuncture, it is therefore reasonable to evaluate whether acupuncture is effective in breast cancer patients who experience musculoskeletal pain related to AIs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 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
Change in Joint Pain
时间窗: Baseline and 6 weeks
This is defined as the difference in the Brief Pain Inventory - Short Form (BPI-SF) scale at six weeks versus baseline.
次要结局
- Change in Joint Stiffness and Function(Baseline and 6 weeks)
- Safety and Tolerability measured by Frequency of Adverse Events(6 weeks)
研究者
Dawn L. Hershman
Associate Professor of Medicine & Epidemiology
Columbia University