The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 4
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II) sham treatment. In groups (I) and (II), acupuncture or sham acupuncture treatment will be given twice a week for 6 weeks (12 sessions). A maintenance tapering treatment schedule will then be applied once per month for 3 months (3 sessions). The primary outcome will be improvement in sleep quality as measured by the change of ISI after 6 weeks of treatment. Secondary outcome assessment tools will include PSQI, HADS, BPI, BFI, FACT-B, sleep diaries, drug diaries, blinding success questionnaire and reports of adverse events. The subjects will be scheduled for on-site follow-up assessments at 3 and 6 months after the last treatment. An intention to treat (ITT) approach will be used for data analysis.
详细描述
Insomnia is a frequent and disturbing symptom among cancer patients. Studies have found that cancer treatments, particularly chemotherapy, are a major cause of cancer-related insomnia. However, insomnia is under-treated in most breast cancer patients because effective, safe evidence-based treatments are lacking.
Acupuncture has been used for thousands of years to treat various diseases, including insomnia. Our previous research demonstrated the efficacy and safety of acupuncture as a treatment for insomnia. However, the effect of acupuncture on insomnia in breast cancer patients who undergo chemotherapy has been rarely studied. We propose this randomized controlled trial to examine the feasibility, effect and safety of acupuncture as a treatment for insomnia in breast cancer patients who undergo chemotherapy.
Hypothesis
We hypothesize that acupuncture is a feasible, effective and safe method for the alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a sham control.
Primary Aim: To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the sham control group, as measured by the ISI after 6 weeks of treatment.
Secondary Aims: 1) To determine whether other sleep-related parameters in the acupuncture group improve more than those of the control group, as measured at different time points by Actiwatch, sleep diary, Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and Brief Pain Inventory (BPI). 2) To assess by adverse event (AE) analysis whether acupuncture is safe for treatment of insomnia in breast cancer patients undergoing chemotherapy.
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
- Triple (Participant, 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
- •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).
- •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
Insomnia Severity Index (ISI)
时间窗: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
The primary outcome will be the change of ISI score between the baseline and the end of the 6-week treatment. The ISI is a seven-item questionnaire devised to diagnose and assess the severity of insomnia.
次要结局
- Brief Pain Inventory-Short Form (BPI-SF)(Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.)
- Actiwatch(Baseline, 6 week.)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.)
- Sleep diary(Baseline, 6 week.)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.)
- Brief Fatigue Inventory (BPI)(Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.)
- Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)(Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.)
研究者
Prof. Zhang Zhang-Jin
Professor
The University of Hong Kong