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IRCT20180722040556N5 IRCT 2020-08-27 Esfahan University of Medical Sciences Evaluation of the effect of melatonin in the treatment of problems caused by androgen deprivation therapy in prostate cancer patients Evaluation of the effect of Melatonin in treatment of menopausal like problems, mood and sleep chaging caused by androgen deprivation therapy in prostate cancer patients 2020-05-18 anticipated 66 Complete https://irct.ir/trial/49824 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is 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 is selected). The total number of patients (sample size 66) is 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 is allocated in order to determine the type of included group. The predicted sample size of patients are accomplished randomly by using this method. The main investigator allocates the concealed code to control group or case group according to random numbers and puts 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 Prostate 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) All adult men (18 years and older) with prostate cancer treated with androgen deprivation therapy (ADT) Patients with controlled hypertension Patients who complain from menopausal complications such as hot flashes (at least 4 times a week in the past month) Patient who has sufficient compliance and ability to take melatonin orally 18 years no limit Male Patients in the metastatic stage of prostate cancer Patients with a history of other malignancies except prostate cancer Concomitant treatment with progesterone agents or other treatments related to hot flashes Concomitant treatment with chemotherapy, radiotherapy or surgery in the future Patients receiving drugs such as propranolol (due to the relative effect on the central nervous system) and warfarin (due to the high risk of drug interactions) No history of liver and kidney disorder or advanced heart failure Patients with a history of allergy to melatonin-containing products Recent use of SSRIs, SNRIs, antiepileptic drugs, and monoamine oxidase inhibitors Patients taking sedative drugs such as benzodiazepines or non-benzodiazepines (such as zolpidem) regularly due to sleep problems C61 Malignant neoplasm of prostate 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 after intervention. Method of measurement: Hot Flash Diary and Hot Flash Related Daily Interference Scale questionnaire. Esfahan University of Medical Sciences Approved 2020-04-15 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)