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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180722040556N5

Enrollment

Registered

2020-08-27

Start date

2020-05-18

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer. Malignant neoplasm of prostate

Interventions

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 follo

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Moghaddas

Esfahan University of Medical Sciences

azadeh_moghaddas@yahoo.com+98 31 3792 7074

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026