Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Chinese version of the Brief Fatigue Inventory (BFI-C)
研究概览
简要总结
Cancer-related fatigue (CRF) is the most common and distressing symptom associated with tumor or cancer treatment that breast cancer survivors (BCS) experience.The investigators previously found the laser moxibustion was potentially efficacious for CRF; however, more rigorously designed study is needed to confirm its benefit. The primary aim of this study is to determine the efficacy of 10.6µm infrared laser moxibustion and its long-term effects on CRF. Secondary aims are to evaluate the effect of infrared laser moxibustion on co-existing symptoms such as among BCS experiencing CRF.
详细描述
The randomized, placebo-controlled, three-arm trial will be conducted to evaluate the efficacy of infrared laser moxibustion (ILM) and sham ILM (SILM) compared to waitlist control (WLC) for moderately to severely fatigued BCS. The two intervention groups will receive real/sham infrared laser moxibustion on four acupoints (e.g. ST36 (bilateral), CV4, and CV6) for 20 minutes each session for six weeks (two times per week). The primary endpoint is the change in fatigue scores from Baseline to Week 6 as measured by the Chinese version of the Brief Fatigue Inventory (BFI-C). Our secondary aims are to compare the severity of comorbidities (e.g. depression, insomnia, and pain) and biological outcomes (e.g. telomere length) among the three groups.
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
- •Age between 18 years and 75 years
- •Breast cancer survivors with a diagnosis of stage I-IIIa
- •Cessation of cancer-related treatments (e.g. surgery, chemotherapy, radiotherapy) at least 12 weeks before the trial, with the exception of hormonal and trastuzumab therapy
- •Complaint of fatigue starting on or after their cancer diagnosis,Brief Fatigue Inventory score of ≥ 4
排除标准
- •Severe anemia (platelet count <60,000/μL,hemoglobin <8 g/dL, or leukocyte count<3000/μL)
- •Abnormal findings in a thyroid function test (abnormal level of free thyroxine and thyroid stimulating hormone <0.1 μIU/ml or TSH> 5.1 μIU/ml)
- •Having received acupuncture for any indication in the previous 4 weeks or having received acupuncture test within the past 6 months.
- •Untreated major depressive disorder and suicidal ideations.
- •Pregnant or planning to become pregnant
结局指标
主要结局
Chinese version of the Brief Fatigue Inventory (BFI-C)
时间窗: Change from Baseline BFI-C at 6 weeks
The Chinese version of the Brief Fatigue Inventory (BFI) : It uses 10-point numeric descriptions: scores of 1 to 3 represent mild levels of fatigue, scores of 4 to 6 represent moderate levels of fatigue, and scores of 7 to 10 represent severe levels of fatigue.
次要结局
- Quality of Life (QOL)(0week; 3weeks；6weeks; 12weeks; 18weeks)
- Brief Pain Inventory(0week; 3weeks；6weeks; 12weeks; 18weeks)
- Insomnia(0week; 3weeks；6weeks; 12weeks; 18weeks)
- Depression/Anxiety(0week; 3weeks；6weeks; 12weeks; 18weeks)
- Stress(0week; 3weeks；6weeks; 12weeks; 18weeks)
- Treatment Expectancy(0week; 3weeks；6weeks)