Skip to content

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180722040556N3
Enrollment
60
Registered
2020-04-18
Start date
2020-05-19
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The amount and severity of hot flash. Timepoint: Before intervention and 4 weeks. Method of measurement: Menopause Rating Scale (MRS) questionnaire.

Secondary

MeasureTime frame
Sexual function. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Female Sexual Function Index 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