The Clinical Outcome of Adjuvant Chemotherapy in Conjunction With Traditional Chinese Medicine in Breast Cancer Patients -a Observational Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
This 2-year trial is intended to be used to study breast cancer patients through forward-looking generation design through collaboration between Chinese and Western medical teams. The whole study consists of 2 stages, stage I comprises a cross-sectional study-baseline and stage II is a cohort for outcome evaluation and follow-up study across a 3-year period. To provide an empirical basis for combined TCM treatment in the Breast Cancer Research Team and to publish that as a reference for future TCM and Western medicine in integrative cancer treatment.
详细描述
Breast cancer is a major health issue for women worldwide and has increased exponentially in the last decades. Improved earlier detection combined with adjuvant systemic therapy is responsible for much of the reduction in cause-specific mortality from breast cancer. Chemotherapy after surgery can decrease the risk of recurrence and is often used as routine treatment in clinic. Because of the fact that a considerable number of patients seek for traditional Chinese medicine (TCM) during adjuvant chemotherapy, it is thus need to evaluate the correlation between TCM treatment and prognosis. The investigators design a single center, prospective cohort study began in November 2018 in Kaohsiung, Taiwan. A sample of 104 participants diagnosed with early breast cancer was recruited from Breast Cancer Research Team and are followed up every 3 to 6 months till October 2023. Detailed information of participants includes general information, history of cancer, quality of life, side effects of chemotherapy and safety of treatment, body constitution of TCM and meridian energy analysis is taken face-to-face at baseline.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged > 20 years old female patients;
- •Patients with histologically proven stage 1-3 breast cancer after surgery;
- •The duration from the end of radical surgery to the beginning of the trail is less than 1 month;
- •ECOG score is 0-2 points;
- •Agreed to participate in this study and signed informed consent.
排除标准
- •Combined with inadequate heart, liver, kidney and hematopoietic function and other serious diseases;
- •Pregnant and lactating women;
- •Patients with a history of mental illness;
- •Patients with distant metastasis and/or expected lifetime less than 3 months;
- •Patients undergoing other medicinal herbs outside our hospital.
结局指标
主要结局
disease-free survival
时间窗: 3 years
3-year disease-free survival
次要结局
- QOLs measurement-1(6 months)
- meridian energy(6 months)
- Side effects of adjuvant chemotherapy(6 months)
- TCM pattern(6 months)
- QOLs measurement-2(6 months)
研究者
Ming-Yen Tsai
Department of Chinese medicine
Chang Gung Memorial Hospital