Breast Cancer Chemotherapy Risk Prediction Mathematical Model

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Macro-microscopic Syndrome Differentiation and Combination，Based on the Chinese Medicine Clinical Phenotype to Construct Breast Cancer Chemotherapy Risk Prediction Mathematical Model

Conditions
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Breast Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All<br>The side effects after chemotherapy were observed for all patients. Potential risk factors would be explored for the side effects such as chemotherapy realted vomit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myelosuppression of chemotherapy | 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. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy related vomit (side effects of chemotherapy) | Outcome is a bianry outcome, Yes or No variable. The secondary outcome is wether the chemotherapy realted vomit occurred or not for patients during the chemotherapy. | 6 month |