The effect of concurrent administration of melatonin and neoadjuvant Chemotherapy on the pathological response in breast cancer patients
Phase 3
Recruiting
- Conditions
- Breast Cancer.Malignant neoplasm: Breast, unspecifiedC50.9
- Registration Number
- IRCT20200409047007N3
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 52
Inclusion Criteria
Patients with stage one to three breast cancers
Age 30 to 60 years at the time of starting chemotherapy
Exclusion Criteria
No previous history of chemotherapy
Absence of contraindications to neoadjuvant chemotherapy for breast cancer including heart failure and drug sensitivity
Absence of uncontrolled diabetes, renal failure with glomerular filtration less than 30 and liver failure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological response. Timepoint: surgery after neoadjuvant chemotherapy. Method of measurement: The pathological response after neoadjuvant chemotherapy is assessed according to the Chevallier system as follows:1- Pathological complete response: Disappearance of all the tumor cells in breast and lymph nodes2- Pathological partial response: Presence of invasive carcinoma with stromal alterations3- Pathological no response: little modification in the original tumor appearance.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: At beginning and end of chemotherapy. Method of measurement: EORTC QLQ – BR23 questionnaire.