IRCT20180722040556N5
Recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Esfahan University of Medical Sciences
- Enrollment
- 66
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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