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IRCT20180722040556N3 IRCT 2020-04-18 Esfahan University of Medical Sciences Melatonin in the management of breast cancer patients Melatonin in the management of menopausal complication, mood and sleep changes due to hormonal therapy in breast cancer patients 2020-05-19 anticipated 60 Complete https://irct.ir/trial/47051 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by Blocked randomization method. Information such as the number of intervention groups (two main intervention groups, for example, A and control, for example, B), block size (multiple numbers of groups, in this study to reduce complexity, 4 will be selected). The total number of patients (sample size 60) will be entered into Internet-specific software for this calculation (for example, available at " the Create a blocked randomisation list | Sealed Envelope"). For each included patients, a specific code will be allocated in order to determine the type of included group. The predicted sample size of patients will be accomplished randomly by using this method. The main investigator will allocate the concealed code to control group or case group according to random numbers and will put them to investigators who are in charge of sampling, Blinding description: For keeping participants, investigator and health care providers blind, whole melatonin tablets will be extracted from blister and separated in 60-tablets considered packages by the main investigator. Finally, all drugs and placebo packages will be labelled by codes extracted from internet-based software. After completion of recruitment, each patients code were coordinated with software data and investigator or health care providers will be informed after data analyses of drugs' codes. 3 Breast cancer. Intervention 1: Intervention group: Administration of 3 mg tablet of melatonin provided by Razak pharmaceutical Company, 6 mg daily (twice a day orally) for 4 weeks and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. Intervention 2: Control group: Administration of identical placebo tablet similar to melatonin tablet which have been provided by Razak pharmaceutical Company twice a day orally for 4 weeks and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. Yes - There is a plan to make this available What will be shared: All collected data When: From the summer of 2021 To whom: All academic centres Conditions: All documents with citation Where to obtain: E-mail address How to obtain: After sending a request, we will call the related person and the data will be revealed in less than one week. Comments:
public Azadeh Moghaddas
Faculty of Pharmacy, Isfahan University of medical Sciences, Hezar jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences scientific Azadeh Moghaddas
Faculty of Pharmacy, Isfahan University of medical Sciences, Hezar jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Female 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 C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: Administration of 3 mg tablet of melatonin provided by Razak pharmaceutical Company, 6 mg daily (twice a day orally) for 4 weeks and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. Control group: Administration of identical placebo tablet similar to melatonin tablet which have been provided by Razak pharmaceutical Company twice a day orally for 4 weeks and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. The amount and severity of hot flash. Timepoint: Before intervention and 4 weeks. Method of measurement: Menopause Rating Scale (MRS) questionnaire. Sexual function. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Female Sexual Function Index questionnaire. Isfahan University of Medical Sciences Approved 2020-03-04 Ethics committee of Isfahan University of Medical Sciences Faculty of Pharmacy, Isfahan University of medical Sciences, Hezar jarib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)