Breast Cancer Chemotherapy Risk Prediction Mathematical Model
BCCRPMM
Macro-microscopic Syndrome Differentiation and Combination，Based on the "Chinese Medicine Clinical Phenotype" to Construct Breast Cancer Chemotherapy Risk Prediction Mathematical Model
1 other identifier
observational
795
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedAugust 10, 2016
August 1, 2016
1.5 years
September 7, 2015
August 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Chemotherapy related vomit (side effects of chemotherapy)
6 month
Study Arms (1)
All
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.
Eligibility Criteria
breast cancer patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Liu, MD,PHD
+86 18991232576
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2015
First Posted
September 11, 2015
Study Start
September 1, 2015
Primary Completion
March 1, 2017
Study Completion
May 1, 2017
Last Updated
August 10, 2016
Record last verified: 2016-08