Breast Cancer. Malignant neoplasm: Breast, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Patients are prescribed a 10 mg tablet of melatonin at bedtime during a 5-month course of chemotherapy. Intervention 2: Control group: Patients in the control group
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients with stage one to three breast cancers Age 30 to 60 years at the time of starting chemotherapy
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: At beginning and end of chemotherapy. Method of measurement: EORTC QLQ – BR23 questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mohsen Seddigh Shamsi
Mashhad University of Medical Sciences
Outcome results
None listed