Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 228
- 试验地点
- 6
- 主要终点
- Response rate of psychoneurological symptom cluster (after 8 weeks of treatment)
研究概览
简要总结
This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy.
Researchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast cancer survivors with the psychoneurological symptom cluster who are currently being treated with endocrine therapy.
Participants will receive 16 treatments over 8 weeks. The EA group will receive true acupuncture with continuous wave stimulation (2Hz, intensity as tolerated) administered for 30 minutes per session. The SA group will receive sham acupuncture using blunt (non-penetrating) needles that contact the skin without penetration, along with a 30-second transient device activation instead of the 30-minute continuous stimulation.
Treatment outcomes for pain, fatigue, insomnia, anxiety, depression and subjective cognitive function will be assessed. The primary outcome is response rate of the psychoneurological symptom cluster after 8 weeks of treatment. Secondary outcomes include changes from baseline in the scores of each of the six psychoneurological symptoms.
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 (Participant, Outcomes Assessor)
盲法说明
Due to the specific nature of acupuncture clinical research, it is difficult to achieve double-blinding of participants and acupuncturists. Accordingly, this trial will blind only participants and outcome assessors. The outcome assessors will be independent of the study and will remain unaware of group allocation.
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, aged 18-75 years;
- •Histologically confirmed Stage 0, I, II, or III breast cancer (according to the AJCC 8th edition)；
- •Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least 1 month prior to study initiation , and are currently receiving endocrine therapy；
- •Meet at least 2 of the following 6 criteria:
- •(1)Visual Analogue Scale (VAS) score for pain ≥ 4 (2)Pittsburgh Sleep Quality Index (PSQI) score ≥ 8 (3)Brief Fatigue Inventory-Chinese version (BFI-C) score ≥ 4 (4)Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score ≥ 8 (5)Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score ≥ 8 (6)Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments (FACT-Cog-PCI) score < 60 ; 5.Has signed the informed consent form and voluntarily participates in this study.
排除标准
- •History of psychiatric disorders (e.g., bipolar disorder, schizophrenia, substance addiction)
- •Presence of diseases that may impair cognitive function or interfere with study assessments (e.g., Alzheimer's disease, Parkinson's disease, brain tumors).
- •Fatigue attributable to a treatable condition (e.g., hypothyroidism).
- •Severe debilitation or significant organic disease (e.g., heart failure, severe hepatic/renal insufficiency, severe anemia, uncontrolled infection).
- •Use of anxiolytics, antidepressants, psychostimulants, or sedative-hypnotics within the past 4 weeks.
- •Chronic use of corticosteroids.
- •Prior acupuncture treatment within 3 months, or participation in an acupuncture or drug clinical trial within 6 months.
- •History of hemorrhagic disease, severe coagulation dysfunction, or current use of anticoagulants (e.g., warfarin).
- •Implanted cardiac pacemaker.
- •Pregnancy or breastfeeding.
- •Concurrent participation in another clinical study.
研究组 & 干预措施
EA group
Participants undergo 16 sessions of electroacupuncture twice weekly over 8 weeks.
干预措施: electroacupuncture (Device)
SA group
Participants undergo 16 sessions of sham electroacupuncture(noninsertive simulated acupuncture and sham electrical stimulation) twice weekly over 8 weeks.
干预措施: sham electroacupuncture (Device)
结局指标
主要结局
Response rate of psychoneurological symptom cluster (after 8 weeks of treatment)
时间窗: Week 8
The response rate is defined as the proportion of participants classified as responders. Improvement in each of the six psychoneurological symptoms is assessed using the following validated instruments: pain is measured by the Visual Analogue Scale (VAS); sleep quality by the Pittsburgh Sleep Quality Index (PSQI); fatigue by the Chinese version of the Brief Fatigue Inventory (BFI-C); anxiety and depression by the Hospital Anxiety and Depression Scale (HADS); and subjective cognitive function by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). A participant is deemed a responder if the post treatment improvement from baseline meets or exceeds the minimum clinically important difference (MCID) for at least two of the six symptoms.
次要结局
- Response rate of psychoneurological symptom cluster (after 4 weeks of treatment and 12-week follow-up)(Week 4, Week 12)
- Change from Baseline in the Functional Assessment of Cancer Therapy-Breast (FACT-B) Score(Baseline (Week 0), Week 4, Week 8, Week 12)
- Change from Baseline in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Total and Subscale Scores(Baseline (Week 0), Week 4, Week 8, Week 12)
- Change from Baseline in the Visual Analogue Scale (VAS) Score for Cancer/Treatment-Related Pain(Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12)
- Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Score(Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12)
- Change from Baseline in the Brief Fatigue Inventory-Chinese Version (BFI-C) Score(Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12)
- Change from Baseline in the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) Score(Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12)
- Change from Baseline in the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) Score(Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12)
- Acupuncture Expectation Evaluation(Within 5 minutes after the first treatment)
- Blinding assessment(Within 5 minutes after the first treatment， Within 5 minutes after the last treatment)
- Safety Assessment(The entire study period (Week 0 [Baseline] to Week 12 [Follow-up]))
研究者
Yan Shiyan
Principal Investigator
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine