Effect of Melatonin on radiation induced fatigue

Comparison of the effectiveness of Melatonin with placebo on radiation induced fatigue in breast cancer patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220907055912N1

Enrollment

100

Registered

2023-02-07

Start date

2023-02-20

Completion date

Unknown

Last updated

2023-03-13

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

Intervention 1: Intervention group: In this group, patients take two 10 mg melatonin tablets every night during radiation therapy. Melatonin drug is prepared from Jalinous pharmaceutical company. Inte

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18-65 years old Performance status KPS=70 (?? ECOG score=0-1) Newly diagnosed breast cancer patient Indication of adjuant chemotherapy Indication of adjuant radiotherapy AC-T chemotherapy regimen

Exclusion criteria

Exclusion criteria: Lack of consent to participate in the study Kidney, Heart and Liver chronic disease History of previous malignant disease History of previous Radiation therapy Metastasis at presentation

Design outcomes

Primary

Measure	Time frame
Fatigue score in MIF questionnaire and stress score in BDI. Timepoint: Before intervention and after intervention. Method of measurement: MIF fatigue measurement questionnaire, BDI-2 questionnare.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSadaf Sadeghi yazdankhah

Shiraz University of Medical Sciences

ssadeghiy@yahoo.com+98 71 3638 0193

Outcome results

None listed

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