NCT07183813尚未招募不适用
Effects of Acupuncture for Anxiety and/or Depression Among Patients With Breast Cancer
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
研究概览
简要总结
The aim of this study is to evaluate the effects and safety of acupuncture on anxiety and/or depression among patients with breast cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 18 to 70 years old;
- •Meeting the diagnostic criteria for breast cancer and at TMN I-III;
- •Having completed specialized active treatment for at least one month;
- •With an ECOG score of 0-2;
- •Mild to moderate anxiety and/or depression;
- •Voluntarily joining this study and signing the informed consent form.
排除标准
- •Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment;
- •Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months;
- •With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer;
- •Patients with suicidal tendencies, bipolar disorder and psychotic symptoms;
- •Patients with severe anxiety and/or depression；
- •Patients received acupuncture treatment within one month before enrolment;
- •Participating in other clinical studies on the treatment of anxiety and/or depression;
- •Combined with severe underlying diseases;
- •Patients with severe skin ulcers;
- •Pregnant or lactating patients;
- •Poor compliance.
结局指标
主要结局
The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
时间窗: week 8
The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
次要结局
- The change from baseline in the total score of HADS.(weeks 4, 12, 16 and 20)
- The change from baseline in the score of HADS-A and HADS-D(weeks 4, 8, 12, 16 and 20)
- Proportion of participants with a total HADS score less than 15, an HADS-A score of less than or equal to 7, and an HADS-D score of less than or equal to 7(weeks 4, 8, 12, 16 and 20)
- Change from baseline in Hamilton Depression Scale-14(Week 4, 8 and 20)
- Change from baseline in Hamilton Depression Scale-17(Week 4, 8 and 20)
- The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)(weeks 4,8 and 20)
- The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)(weeks 4, 8 and 20)
- The change from baseline in the brief fatigue inventory (BFI)(weeks 4, 8 and 20)
- The change from baseline in the Insomnia Severity Index (ISI)(weeks 4, 8 and 20)
- The proportion of responders per the Patient Global Index of Improvement (PGI-I)(weeks 8 and 20)
- Collection of cranial MRI images.(baseline and week 8)
- The change from baseline in the total score of HADS.(weeks 4, 12, 16 and 20)
- The change from baseline in the score of HADS-A and HADS-D(weeks 4, 8, 12, 16 and 20)
- Change from baseline in Hamilton Depression Scale-14(Week 4, 8 and 20)
- Proportion of participants with a total HADS score less than 15, an HADS-A score of less than or equal to 7, and an HADS-D score of less than or equal to 7(weeks 4, 8, 12, 16 and 20)
- Change from baseline in Hamilton Depression Scale-17(Week 4, 8 and 20)
- The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)(weeks 4,8 and 20)
- The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)(weeks 4, 8 and 20)
- The change from baseline in the brief fatigue inventory (BFI)(weeks 4, 8 and 20)
- The change from baseline in the Insomnia Severity Index (ISI)(weeks 4, 8 and 20)
- The proportion of responders per the Patient Global Index of Improvement (PGI-I)(weeks 8 and 20)
- Collection of cranial MRI images.(baseline and week 8)
研究者
Yuanjie Sun
Attending physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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