NCT03762694已完成不适用
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index (ISI)
研究概览
简要总结
This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.
详细描述
Hypothesis:
Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a wait-list control.
Objective:
To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the wait-list control group.
Design and strategy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between 18 and 75 years of age;
- •Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;
- •Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;
- •Insomnia onset after the diagnosis of breast cancer;
- •Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder;
- •Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;
- •Expected survival time of more than 6 months;
- •Ability to understand the nature of the study and willingness to give informed consent;
- •Ability to provide responses during outcome measurement.
排除标准
- •Insomnia before the diagnosis of breast cancer;
- •Other sleep disorder (e.g., obstructive sleep apnoea);
- •Shift work or irregular sleep pattern;
- •Severe visual, hearing or language defects;
- •Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);
- •With pacemakers or other electronic implants that could interfere with electroacupuncture;
- •History of acupuncture use in the previous 3 months;
- •Participation in other clinical trials with intervention within 3 months of the beginning of the trial.
结局指标
主要结局
Change in Insomnia Severity Index (ISI)
时间窗: week 0, 3, 6 (primary outcome), 10, 14
次要结局
- Actigraphy(week 0, 6)
- Pittsburgh Sleep Quality Index(week 0, 3, 6, 10, 14)
- Adverse events(week 0 to week 6)
- Sleep diary(week 0, 6)
- Functional Assessment of Cancer Therapy-Breast Cancer(week 0, 6, 10, 14)
研究者
Professor LAO Lixing
Professor
The University of Hong Kong
研究点 (1)
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