Acupuncture and Aromatase Inhibitor Related Arthralgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain as measured by Brief Pain Inventory (BPI) pain severity score
研究概览
简要总结
RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase inhibitors.
PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.
详细描述
PRIMARY OBJECTIVES:
I. To determine the overall effect of acupuncture for reducing arthralgia among breast cancer survivors (BCS) receiving AIs.
II. To explore the specific effect of acupuncture needling for reducing arthralgia among BCS receiving AIs.
III. To elucidate the relationship between response expectancy measured by the Acupuncture Expectancy Scale (AES) and clinical response to acupuncture defined as percent reduction of BPI pain severity score at the end of intervention.
SECONDARY OBJECTIVES:
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of stage I, II, or III breast cancer
- •Visit with oncologist within the previous 3-month period and free of disease by clinical examination and history
- •Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) as per chart abstraction
- •Postmenopausal, as defined by cessation of menses for a least 1 year or FSH > 40 mlU/mL
- •Can understand written English
- •Having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
- •Having had at least 15 days with pain in the preceding 30 days
- •Having had joint pain for at least 3 months
- •Joint pain attributed to the use of aromatase inhibitors
- •Willingness to adhere to all study-related procedures including randomization to one of the three possible choices: real acupuncture, placebo acupuncture, and wait-list control
- •Women with metastatic (stage IV) breast cancer
- •Women having finished chemotherapy or radiation therapy less than 4 weeks prior to enrollment
- •History of bleeding disorder
- •Joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout, pseudo gout)
- •Having severe pain or non-inflammatory arthralgia prior to AI initiation per patient's history
- •Surgery or joint injection involving the treatment joint within the last 3 months
- •Have previously participated in the acupuncture trial for hot flashes in the last year
排除标准
- 未提供
研究组 & 干预措施
Arm I (Acupuncture)
Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).
干预措施: acupuncture therapy (Procedure)
Arm II (Placebo)
Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.
干预措施: sham intervention (Procedure)
Arm III (Control)
Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.
结局指标
主要结局
Pain as measured by Brief Pain Inventory (BPI) pain severity score
次要结局
- Other coexisting symptoms such as fatigue, psychological distress, and insomnia as assessed by the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index, and City of Hope Quality of Life Questionnaire
- Arthritis/disability specific outcomes as assessed by WOMAC index for lower extremities, quick D.A.S.H. for upper extremities, and the Physical Performance Test, 9-item
- BPI pain-related interference
- Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)