Macro-microscopic Syndrome Differentiation and Combination，Based on the "Chinese Medicine Clinical Phenotype" to Construct Breast Cancer Chemotherapy Risk Prediction Mathematical Model
试验速览
- 阶段
- 不适用
- 入组人数
- 795
- 试验地点
- 1
- 主要终点
- Myelosuppression of chemotherapy
研究概览
简要总结
This is a cohort study. This study is to develop a predictive model of the side effects after chemotherapy, exploreing the potential risk factors of the side effects such as myelosuppression and chemotherapy realted vomit after the chemotherapy, so that it could help to alleviate patients' fear and anxiety about the side effects and the toxicity of chemotherapy. The potential risk factors were measured at baseline.
详细描述
Firstly, the investigator will extact the "macro" information about physical conditon, which comes from syndrome-constitutional differentiation in the light of Traditonal Chinease Medicine (TCM) theory. Then combined with the "micro" information about pathological and biological markers, "TCM clinical phenotype" is extracted by Text Mining, and shows the full picture of the clinical features of breast cancer, which will include most of risk factors related to occurrence of adverse of chemotherapy fo breast cancer patients to establish two corresponding quatitative databases. Furthermore, predictive models will be built according to the predictors selected from an analysis on new methods of econometrics-Granger causality and cointegration analysis between "TCM clinical phenotype" and adverse effects of chemotherapy. The research results will be used to establish effective predictive models to lay the foundation for optimizing individualized treatment program of breast cancer by TCM and Western medicine.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •THe female patients diagnosed with breast cancer by first histopathology;
- •No tumor intervention therapy was conducted within one prior to the survey;
- •KPS score≥60;
- •Patients without sever idiopathic disease;
- •Patients who can independently respond to a questionnaire
- •Those who signed informed consent
排除标准
- •Patients with sever idiopathic disease of the gastrointestinal tract, heart and blood vessels, liver,kidney, hematopoietic system, endocrine system and so on;
- •Patients with previous or nogoing application of drugs affecting bone marrow hemoatopoietic function;
- •Patients who complicated with a serious infection or severe liquid sickness;
- •Psychiatric patients;
- •Those who can not independently respond to a questionnaire
结局指标
主要结局
Myelosuppression of chemotherapy
时间窗: 6 month
Outcome is a bianry outcome, Yes or No variable. The primary outcome is wether the bone marrow suppression occurred or not for patients during the chemotherapy.
次要结局
- Chemotherapy related vomit (side effects of chemotherapy)(6 month)