Studying the effect of melatonin in preventing neutropenia following chemotherapy in patients with breast cancer

Studying the effect of melatonin in preventing neutropenia following chemotherapy in patients with breast cancer referred to Imam Khomeini Hospital Complex in Tehran in the fall and winter of 2025.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250918067285N1

Enrollment

Registered

2025-09-25

Start date

2025-09-23

Completion date

Unknown

Last updated

2025-10-13

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: This group is treated with melatonin, a drug produced by Razi Company. The dosage of melatonin is 10 milligrams every night. Intervention 2: Control group: This gro

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Having informed consent Cyclophosphamide and Adriamycin chemotherapy regimen

Exclusion criteria

Exclusion criteria: Uncontrolled hypertension Have a history of seizures Absolute neutrophil count less than 1500

Design outcomes

Primary

Measure	Time frame
Frequency of neutropenia. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: CBC Diff.;Number of times chemotherapy was delayed. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: CBC Diff.;Number of times GCSF was received before starting chemotherapy. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Number of hospitalizations due to neutropenia. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Nausea. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Fatigue. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Neuropathy. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.	—

Measure

Time frame

Frequency of neutropenia. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: CBC Diff.;Number of times chemotherapy was delayed. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: CBC Diff.;Number of times GCSF was received before starting chemotherapy. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Number of hospitalizations due to neutropenia. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Nausea. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Fatigue. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.;Neuropathy. Timepoint: Check-ups during chemotherapy every 2 to 3 weeks (each patient has 4 courses of chemotherapy). Method of measurement: Obtaining a history.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactArsalan Sabamehr

Tehran University of Medical Sciences

Arsalansabamehr@gmail.com+98 31 3233 3218

Outcome results

None listed

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