Evaluation of the effect of melatonin in the treatment of problems caused by androgen deprivation therapy in prostate cancer patients

Phase 3

Recruiting

Conditions: Prostate cancer.
Malignant neoplasm of prostate

Registration Number: IRCT20180722040556N5

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 66

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

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 after intervention. Method of measurement: Hot Flash Diary and Hot Flash Related Daily Interference Scale questionnaire.

Secondary Outcome Measures