Genetic Predictors of Response to Acupuncture for Cancer-related Fatigue Among Breast Cancer Patients After Chemotherapy
研究概览
详细说明
Cancer related fatigue(CRF) in patients with breast cancer has a great impact on their quality of life and treatment compliance. Many studies suggest that acupuncture has certain therapeutic effects on fatigue. In this clinical trial, we treated patients with acupuncture to alleviate their fatigue symptoms. Currently, studies have shown that cancer related fatigue in breast cancer patients is related to some biological factors. While acupuncture is used to treat fatigue, we will collect blood samples from patients for fatigue related single nucleotide polymorphisms（SNP）.
Based on CRF related biological factors, our study aims to screen SNPs that related to CRF related biological factors to guide electroacupuncture in the treatment of cancer-related fatigue and establish a prognostic model.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Qinghai
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Xining、Qinghai、中国、810000
- 招聘中
- Qinghai University Affiliated Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- The patient was diagnosed with breast cancer.;
- Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study;
- Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
- Patients with previous local recurrence were eligible, but not patients with distant metastasis；
- The basic indexes were consistent, and the blood routine and ECG were normal.
Exclusion Criteria:
- The exclusion criteria were patients with needle phobia;
- Low platelet count (<50 000); co-morbidity with a bleeding disorder; co-morbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids；
- Life expectancy <6 months；
- lymphoedematous limbs.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Acupuncture group
Patients with breast cancer who experienced fatigue were measured by the Brief Fatigue Inventory(BFI) scale and other Fatigue related questionnaire.
Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study，and those patients will receive acupuncture treatment.
The position of acupuncture refers to the principle of acupuncture treatment of traditional Chinese medicine.
According to ICD-10-CD code R53.0, the diagnosis of CRF is determined by the experience of diminished energy or other physical and psychological symptoms every day or almost every day for two consecutive weeks in the past month.
We collected patients' blood to detect fatigue related SNP.
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Patients with breast cancer who experienced fatigue were measured by the Brief Fatigue Inventory(BFI) scale and other Fatigue related questionnaire.
Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study，and those patients will receive acupuncture treatment.
The position of acupuncture refers to the principle of acupuncture treatment of traditional Chinese medicine.
According to ICD-10-CD code R53.0, the diagnosis of CRF is determined by the experience of diminished energy or other physical and psychological symptoms every day or almost every day for two consecutive weeks in the past month.
We collected patients' blood to detect fatigue related SNP.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference of BFI score change after treatment
大体时间：2 years
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Brief Fatigue Inventory（ BFI）is a nine item scale used to evaluate the intensity of fatigue and the interference of fatigue to normal activities.
The classification of fatigue severity is: Mild fatigue (1-3), Moderate fatigue (4-6) and Severe fatigue (7-10).
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Side effects related to electroacupuncture
大体时间：2 years
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Side effects related to electroacupuncture
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2 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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