NCT00641303已完成不适用
A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of Acupuncture in Reducing Musculoskeletal Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 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
- 未提供
排除标准
- 未提供
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))
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint PainRecurrent Breast CancerStage I Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerBreast CancerNCT01013337Abramson Cancer Center at Penn Medicine76
Unknown
不适用
Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast CancerStiffness of Hand, Not Elsewhere ClassifiedBreast CancerNCT05098951Affiliated Hospital of Qinghai University52
已完成
不适用
Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast CancerPostmenopausalBreast CancerNCT06228768University of Michigan Rogel Cancer Center50
已完成
不适用
Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell TransplantationCancerNCT00060021National Cancer Institute (NCI)
已完成
不适用
Effects of Acupuncture on Aromatase Inhibitor-Induced Joint PainBreast CancerNCT02548637Saint John's Cancer Institute20