Breast Neoplasms
Conditions
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.
Interventions
None listed
Sponsors
Shaanxi Hospital of Traditional Chinese Medicine
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYi Liu, MD,PHD
Backup ContactYe Sun, MD,PHD
Outcome results
None listed