Melatonin in the management of breast cancer patients
Phase 3
- Conditions
- Breast cancer.Malignant neoplasm of breast
- Registration Number
- IRCT20180722040556N3
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Adult women suffering from hormone-positive breast cancer with grade I to III who are receiving Selective estrogen receptor modulators (SERM) or Aromatase inhibitors (AIs) family drug.
Patients who are complaining from hot flash ( at least 4 times in a previous month)
Patients who have compliance and ability to take melatonin orally
Exclusion Criteria
Patients who are in metastatic stage
Patients who have a history of other malignancies except for breast cancer
Patients who are receiving antipsychotic, anti-depression, anti-anxiolytic, sedative or hypnotic or anti-epileptic drugs
Patients with a history of hypersensitivity reaction to melatonin
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount and severity of hot flash. Timepoint: Before intervention and 4 weeks. Method of measurement: Menopause Rating Scale (MRS) questionnaire.
- Secondary Outcome Measures
Name Time Method Sexual function. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Female Sexual Function Index questionnaire.