Clinical trial NCT02547545: Breast Cancer Chemotherapy Risk Prediction Mathematical Model
Official title: Macro-microscopic Syndrome Differentiation and Combination，Based on the "Chinese Medicine Clinical Phenotype" to Construct Breast Cancer Chemotherapy Risk Prediction Mathematical Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Shaanxi Hospital of Traditional Chinese Medicine
First posted: 2015-09-11
Enrollment: 795
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myelosuppression of chemotherapy
timeFrame: 6 month
Secondary outcomes:
measure: Chemotherapy related vomit (side effects of chemotherapy)
timeFrame: 6 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
Study officials:
affiliation: +86 18991232576
name: Yi Liu, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: