NCT01881516Unknown2 期
Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue（CRF）
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 主要终点
- Brief Fatigue Inventory, BFI
研究概览
简要总结
we plan to conduct this trial to find out：
- If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or radio-therapy？
- How about the extent it relieves？the safety and applicability ？
- What's the possible influential factor and mechanism ？
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are pathologically/cytologically diagnosed as NSCLC and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment;
- •Participants who meet the diagnosis criteria of CRF（ICD-10 criteria);
- •The first time to receive acupuncture treatment;
- •The age is between 18 and 65 years old;
- •Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above;
- •ECOG performance status 0, 1 or
- •Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
- •Have not taken any hypnotic, melatonin, or antidepressants within 30 days;
- •Willing to finish the whole observation period;
- •With written consent form signed by themselves.
排除标准
- •Participants in other clinical research;
- •Can not be pathologically or cytologically diagnosed as NSCLC;
- •ECOG 3~4;
- •Pregnant woman;
- •>65 or <18 years old;
- •Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue;
- •Patients who have received acupuncture ever before;
- •Received surgery, immunotherapy or target therapy within one month before the recruition；
- •Taking warfarin or heparin, a bleeding tendency exists;
- •Infection, ulceration or hyperalgesia at or near the local acupoints' skin，or with active infections；
- •There are cerebral vascular accident history or spinal cord injury history；
- •Combination with other serious diseases or condition, including congestive heart failure, Unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.;
- •Patients with a life expectancy < 3 months;
- •Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.
结局指标
主要结局
Brief Fatigue Inventory, BFI
时间窗: 12 months
次要结局
- MDASI-C(12 months)
- number of adverse events of acupuncture(24 months)
- FACT-L(12 months)
研究者
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