Clinical Observational Studies: Breast Cancer Treatment by Traditional Chinese and Western Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- FACT-B (Functional Assessment of Cancer Therapy - Breast)
研究概览
简要总结
The aim of this study is to investigate the intervention of traditional Chinese medicine (TCM) in managing the side effects experienced by breast cancer patients undergoing conventional Western medical treatments, such as blood cell decline, nausea, vomiting, gastrointestinal discomfort, and overall quality of life. The study aims to establish a long-term clinical enrollment criteria and process for TCM adjuvant therapy in breast cancer. The research design will utilize a prospective cohort study and real-world cross-sectional observational research method to obtain clinical data and survival status of the patients.
详细描述
Two-group parallel experimental design. One group received conventional Western medicine treatment, while the other group received combined treatment with both traditional Chinese and Western medicine treatment.
A. Patients who opt for integrated traditional Chinese medicine (TCM) treatment will be referred to the TCM outpatient department, where a TCM practitioner will prescribe TCM prescriptions, followed by the initial clinical effectiveness assessment.
B. Patients will continue their follow-up visits at the oncology and TCM clinics, receiving both conventional Western medicine treatments and TCM treatments.
C. Both the Western medicine treatments and TCM treatments received by the patients are covered by health insurance, and patients do not need to pay anyadditional fees.
D. Both the "Conventional Western Medicine Treatment Group" and the "Integrated Western and Chinese Medicine Treatment Group" will undergo another clinical effectiveness assessment (blood tests) before the next cancer treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A. Aged 18 years or above.
- •B. Female patients diagnosed with primary breast cancer and receiving Western medical treatment. The included breast cancer diagnosis codes based on ICD-9 are 174 to 179.
排除标准
- •A. Patients with a prior diagnosis of other malignant tumors before being diagnosed with primary breast cancer.
- •B. Patients with primary breast cancer who have not received Western medical treatment, meaning they have not undergone surgical resection, radiation therapy, chemotherapy, or targeted therapy..
- •C. After taking Chinese medicine, those who have uncomfortable symptoms or whose behavior affects Western medicine treatment should withdraw from the trial.
研究组 & 干预措施
Conventional Western Medicine Treatment Group
Patients receive standard Western medical care, including chemotherapy, according to clinical guidelines. No Traditional Chinese Medicine (TCM) is involved. Clinical assessments and questionnaires are administered throughout the treatment course.
干预措施: Chemotherapy drug (Drug)
Integrative Treatment Group (Western Medicine + TCM)
Patients receive both standard Western medical care (e.g., chemotherapy) and Traditional Chinese Medicine (TCM) treatments. TCM is prescribed based on syndrome differentiation and focuses on supporting healthy qi and mitigating side effects. Clinical assessments and questionnaires are administered throughout the treatment course.
干预措施: Integrative Treatment (Chemotherapy + TCM) (Other)
结局指标
主要结局
FACT-B (Functional Assessment of Cancer Therapy - Breast)
时间窗: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The FACT-B is a validated questionnaire used to assess quality of life in breast cancer patients. It includes domains such as physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer-specific concerns.
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30)
时间窗: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The EORTC QLQ-C30 is a validated, cancer-specific, patient-reported quality of life questionnaire. It consists of 30 items covering five functional domains (physical, role, emotional, cognitive, and social), three symptom domains (fatigue, pain, nausea/vomiting), a global health status/QoL scale, and several single items (e.g., dyspnea, insomnia). It is widely used in cancer clinical trials for measuring changes in quality of life during treatment.
WHOQOL-BREF (World Health Organization Quality of Life - BREF)
时间窗: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The WHOQOL-BREF is a 26-item questionnaire developed by the World Health Organization to assess an individual's perception of their quality of life in four domains: physical health, psychological health, social relationships, and environment. It is widely used for evaluating general quality of life in clinical populations.
BCQ (Body Constitution Questionnaire)
时间窗: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The BCQ is a self-reported questionnaire developed based on Traditional Chinese Medicine (TCM) theory. It evaluates individual body constitution types, including Yang deficiency, Yin deficiency, and Stasis constitution. The tool is useful in assessing patients' constitutional status and monitoring changes during treatment, especially in integrative TCM studies.
EQ-5D (EuroQol Five Dimensions Questionnaire)
时间窗: On the day of each chemotherapy cycle (Day 1 of each cycle)
The EQ-5D is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a visual analog scale (VAS) to rate overall health. It is widely used in health economic evaluations and patient-reported outcome assessments.
次要结局
未报告次要终点
研究者
Hsien-Chang Wu
Director of the Department of Traditional Chinese Medicine
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation