NCT07079072尚未招募不适用
The Effects of Acupuncture for Lung Cancer-Related Fatigue, a Clinical Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences0 个研究点目标入组 120 人开始时间: 2025年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- The proportion of patients whose score of average fatigue over the past 24 hours decreased by at least 2 points on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.
研究概览
简要总结
This study aims to evaluate the efficacy and safety of acupuncture in alleviating cancer-related fatigue (CRF) among lung cancer survivors. It addresses the key issue of limited high-quality evidence for acupuncture's effect on CRF by rigorously comparing real acupuncture against a non-penetrating sham needle control in 120 eligible participants. Patients will be centrally randomized (1:1), blinded, and receive 12-session treatment over 4 weeks. Participants will complete treatment and attend follow-up visits up to week 16, and repeatedly complete fatigue (BFI-C, MFI-20), psychological (PHQ-9, GAD-7, FCRI), functional (CWSAS), and sleep (ISI) assessments.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of lung cancer who have completed initial treatment (including surgery, radiotherapy, and/or chemotherapy) at least 8 weeks prior;
- •Aged between 18 and 75 years;
- •Meet the diagnostic criteria for cancer-related fatigue;
- •Estimated to have a survival period of at least 3 months;
- •Patients with moderate to severe cancer-related fatigue (the highest fatigue score in the past 24 hours on the Chinese version of the Brief Fatigue Inventory [BFI-C] ≥ 4 points);
- •ECOG Performance Status score ranges from 0 to 2 points
- •Voluntarily join this study and sign the informed consent form.
排除标准
- •Patients experiencing significant fatigue symptoms before being diagnosed with lung cancer;
- •Patients with severe anxiety and depression;
- •Patients showing notable cognitive impairment or suicidal tendencies;
- •Patients with a history of hypothyroidism or chronic fatigue syndrome;
- •Patients suffering from moderate to severe anemia, with hemoglobin levels below 90 g/L;
- •Patients experiencing severe pain, with a Numeric Rating Scale (NRS) score of 7 or higher;
- •Patients with serious sleep disorders;
- •Patients with severe malnutrition;
- •Patients with seriously diminished physical function;
- •Patients who have undergone acupuncture treatment for cancer-related fatigue within the past month;
- •Patients with uncontrolled severe underlying conditions, such as heart failure, myocardial infarction, unstable angina, endocrine disorders, gastrointestinal issues, neurological impairments, severe infections, liver and kidney failure, or chronic obstructive pulmonary disease;
- •Patients with poor adherence;
- •Patients who are breastfeeding, pregnant, or planning to conceive within the next four months.
研究组 & 干预措施
Acupuncture
Experimental
干预措施: Acupuncture (Device)
sham acupuncture
Sham Comparator
干预措施: Sham Comparator (Device)
结局指标
主要结局
The proportion of patients whose score of average fatigue over the past 24 hours decreased by at least 2 points on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.
时间窗: At the 4th week.
The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more severe fatigue.
次要结局
- The change from baseline in the the average fatigue over the past 24 hours on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.(At the 4, 8, 12, and 16 weeks)
- The proportion of patients whose score on the most severe fatigue over the past 24 hours decreased by 2 points or more on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.(At 4, 8, 12, 16 weeks.)
- The change from baseline in the the most severe fatigue over the past 24 hours on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.(At the 4, 8, 12, and 16 weeks)
- The changes from baseline of Brief Fatigue Inventory-Chinese (BFI-C) scores on quality of life(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Multidimensional Fatigue Inventory (MFI-20) and the scores of each item compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Fear of Cancer Recurrence Inventory (FCRI ) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Chinese work and social adjustment scale (CWSAS) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Patient Health Questionnaire-9 (PHQ-9) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Generalized Anxiety Disorder-7 (GAD-7) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Insomnia Severity Index (ISI) compared to the baseline(At 4, 8, 12, 16 weeks.)
- The percentage of patients who experienced moderate or significant improvement in fatigue, as evaluated by the Patient Global Impression-Improvement (PGI-I) scale.(At 4, 16 weeks.)
- Adverse event(From enrollment to the end of follow-up at 16 weeks)
- Adherence assessment(From enrollment to the end of follow-up at 16 weeks)
- The proportion of patients whose score of average fatigue over the past 24 hours decreased by at least 2 points on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.(At the 8, 12, 16 weeks.)
- The change from baseline in the the average fatigue over the past 24 hours on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.(At the 4, 8, 12, and 16 weeks)
- The proportion of patients whose score on the most severe fatigue over the past 24 hours decreased by 2 points or more on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.(At 4, 8, 12, 16 weeks.)
- The change from baseline in the the most severe fatigue over the past 24 hours on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline.(At the 4, 8, 12, and 16 weeks)
- The changes from baseline of Brief Fatigue Inventory-Chinese (BFI-C) scores on quality of life(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Multidimensional Fatigue Inventory (MFI-20) and the scores of each item compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Fear of Cancer Recurrence Inventory (FCRI ) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Chinese work and social adjustment scale (CWSAS) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Patient Health Questionnaire-9 (PHQ-9) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Generalized Anxiety Disorder-7 (GAD-7) compared to the baseline(At 4, 8, 12, 16 weeks.)
- Changes in the scores of the Insomnia Severity Index (ISI) compared to the baseline(At 4, 8, 12, 16 weeks.)
- The percentage of patients who experienced moderate or significant improvement in fatigue, as evaluated by the Patient Global Impression-Improvement (PGI-I) scale.(At 4, 16 weeks.)
- Adverse event(From enrollment to the end of follow-up at 16 weeks)
- Adherence assessment(From enrollment to the end of follow-up at 16 weeks)
- Concomitant medication(From enrollment to the end of follow-up at 16 weeks)
研究者
Yuanjie Sun
Doctor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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