Breast Cancer Chemotherapy Risk Prediction Mathematical Model

• Conditions: Breast Neoplasms

• Registration Number: NCT02547545
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 795

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myelosuppression of chemotherapy	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.

Secondary Outcome Measures

Name	Time	Method
Chemotherapy related vomit (side effects of chemotherapy)	6 month	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.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, China