Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of breast cancer
- •Concurrent therapy with anastrozole for the adjuvant treatment of breast cancer
- •Must have moderate or worse arthralgia, as defined by a baseline WOMAC pain scale score ≥ 48
- •Patients with other underlying pain syndromes (e.g., osteoarthritis) are eligible, but the arthralgia must have worsened since starting anastrozole
- •Hormone receptor-positive disease
- •PATIENT CHARACTERISTICS:
- •Post-menopausal status meeting the following criteria:
- •At least 12 months without spontaneous menstrual bleeding
- •History of bilateral salpingo-oophorectomy with or without hysterectomy
- •Age > 55 with hysterectomy with or without oophorectomy
- •Age < 55 with hysterectomy without oophorectomy or with unknown status, and serum FSH in post-menopausal range within the past 4 weeks
- •Not needle phobic
- •Patients with a contraindication to NSAIDs (i.e., prior gastrointestinal bleed secondary to NSAIDs or severe renal insufficiency) are eligible, but will be treated with alternative analgesics such as narcotics or acetaminophen
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Concurrent chronic narcotics or NSAIDs allowed, but doses must be stable for ≥ the past month
- •Concurrent antidepressant medications allowed, but doses must be stable for ≥ the past 3 months
- •At least 6 months since prior acupuncture
- •No prior acupuncture for aromatase inhibitor-associated pain syndrome
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks.
干预措施: acupuncture therapy (Procedure)
Arm II
Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I.
干预措施: pain therapy (Procedure)
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