A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of Acupuncture in Reducing Musculoskeletal Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Health Assessment Questionnaire Disability Index (HAQ-DI) score
研究概览
简要总结
RATIONALE: Acupuncture may help relieve muscle and bone pain caused by aromatase inhibitor therapy, such as letrozole, exemestane, and anastrozole.
PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works in reducing muscle and bone symptoms in women receiving letrozole, exemestane, or anastrozole for stage 0, stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine if acupuncture can reduce aromatase inhibitor (AI)-associated musculoskeletal symptom severity, in terms of function and pain, in woman with stage 0-III breast cancer.
Secondary
- To assess if acupuncture decreases oral analgesic use in these patients.
- To assess if acupuncture decreases the proportion of patients who change or discontinue AI therapy.
- To assess if acupuncture improves menopausal symptoms, mood (i.e., depression or anxiety), sleep quality and sleep disturbance, and overall quality of life of these patients.
- To assess if acupuncture changes plasma concentrations of estrogens (i.e., E1, E2, and E1S), cytokine profile, and beta endorphin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive carcinoma of the breast
- •Stage 0-III disease
- •Estrogen receptor- and/or progesterone receptor-positive by immunohistochemical staining
- •Must be receiving a standard dose of aromatase inhibitor (AI) therapy (i.e., letrozole 2.5 mg once daily, exemestane 25 mg once daily, or anastrozole 1 mg once daily)
- •AI therapy has been ongoing for ≥ 1 month and treatment is expected to continue
- •AI-associated musculoskeletal symptoms, defined as ≥ 1 of the following:
- •Physician-confirmed AI-associated musculoskeletal symptoms
- •Patients concurrently enrolled on the clinical trial, "A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response with Aromatase Polymorphism," and who have met the referral criteria for a rheumatological evaluation
- •No known metastatic (stage IV) breast cancer
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Menopausal status not specified
- •PRIOR CONCURRENT THERAPY:
- •No prior acupuncture within past 12 months.
- •No other concurrent systemic therapy (i.e., chemotherapy, biologic therapy, or radiotherapy) unless approval is given by the Protocol Chair
排除标准
- 未提供
研究组 & 干预措施
Arm I (control)
Patients receive 8 weekly sessions of sham acupuncture treatment comprising 20 minutes of a non-penetrating device consisting of a retractable needle and an adhesive tube on the skin using the Park Sham Device (PSD) in 14 non-acupuncture points. Patients may receive 4 free acupuncture sessions (not sham) after the 12 or 24-week follow-up visit.
干预措施: sham intervention (Procedure)
Arm II (treatment)
Patients receive 8 weekly sessions of acupuncture treatment comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4, CV 6, CV12 and bilateral LI 4, MH 6, GB 34, ST 36, KI 3, BL 65.
干预措施: acupuncture therapy (Procedure)
结局指标
主要结局
Health Assessment Questionnaire Disability Index (HAQ-DI) score
时间窗: Baseline, Weeks 4, 8 and 12 (or Week 24)
Pain scores on visual analog scale (VAS)
时间窗: Baseline, Weeks 4, 8 and 12 (or Week 24)
次要结局
- Number of patients who discontinue or change AI therapy(All timepoints)
- Change in plasma estrogen concentrations, beta endorphin concentration, and cytokine profile from week 0 to week 8(Baseline, Week 8)
- Change in amount and/or frequency of oral analgesic use(Baseline, Weeks 1-8, Week 12 (or Week 24))
- Change in menopausal symptoms (NSABP-revised), hot flash frequency (HFRDIS), sleep quality (PSQI), depression score (CESD), and overall quality of life (EuroQOL) in patients at weeks 4, 8, and 24 vs week 0 of acupuncture treatment(Baseline, Weeks 4, 8 and 12 (or Week 24))