follow up of Effects of Melatonin on Fatigue Associated associated with radiotherapy and chemotherapy

Two-year follow up of a Randomized, Controlled Trial: the Effects of Melatonin on Fatigue Associated with Breast Cancer and Its Adjuvant Treatments

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180426039421N3

Enrollment

Registered

2022-07-17

Start date

2020-03-20

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Breast Cance

Interventions

Intervention 1: Intervention group: Oral Melatonin drug 6 mg( 2 capsule of 3 mg) will be taken every night from 3 to 7 days before the start of the adjuvant treatment up to 2 years later. Intervention

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Breast Cancer Stages I, II, III According to Pathological Reports Patients at least 18 Years Old Have Signed a Written Consent Recevieng Adjuvant Chemotherapy and Radiotherapy No Untreated Hypercalcemia No Systolic Blood Pressure Less Than 100 mm Hg No Warfarin Consumption No Methylphenidate Consumption No Sleep Pills During Melatonin Use No TSH>5/5 or <0/5 No Pregnancy or Breastfeeding

Exclusion criteria

Exclusion criteria: Not signing a written consent

Design outcomes

Primary

Measure	Time frame
Fatigue severity in the BFI questionnaire. Timepoint: 2 years after last adjuvant treatment session. Method of measurement: Brief Fatigue Inventory( BFI) questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Keshtpour Amlashi

Hamedan University of Medical Sciences

z.keshtpour@edu.umsha.ac.ir+98 81 3838 1076

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026