Evaluation of nephroprotective effects of Melatonin

Evaluation of nephroprotective effects of Melatonin in cancer patients treated with Cisplatin

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20171225038073N1

Enrollment

Registered

2018-08-30

Start date

2018-07-23

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

Lung? head and neck? genitourinary system or gastrointestinal cancers. C07 Malignant neoplasm of parotid gland , C08 Malignant neoplasm of other and unspecified major salivary glands, C09 Malignant neoplasm of tonsil , C10 Malignant neoplasm of oropharynx, C11 Malignant neoplasm of nasopharynx, C12 Malignant neoplasm

Interventions

Intervention 1: Intervention group: Melatonin with dose of 20 mg (two Melatonin 10 mg tablets) from Best naturals company will be prescribed every night from at least 1 day before Cisplatin administra

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: = 18 years of age Cancer patients who receive Cisplatin with =50 mg/m2 of dose in one day and the chemotherapy courses are repeated every 3 weeks Patients who do not use other nephrotoxic chemotherapy drugs Glomerular filtration rate (GFR)>45 ml/min (modification of diet in renal disease (MDRD) formula) Patients with one of lung? head and neck? genitourinary system, gastrointestinal cancers Karnofsky status = 60% Normal liver function

Exclusion criteria

Exclusion criteria: Kidney cancer Inability to take oral medication Heart failure Active infection The history of using other nephrotoxic drugs (e.g. Vancomycin, Aminoglycoside, Amphotericin and NSAID) within the previous 2 weeks The patients who are using angiotensin-converting-enzyme inhibitor (ACE inhibitor) & angiotensin receptor blockers (ARB) medicines

Design outcomes

Primary

Measure	Time frame
Urine Neutrophil gelatinase-associated lipocalin (NGAL) level. Timepoint: Urine NGAL level measurement dose before Cisplatin administration , 6 h and 24 h after. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method.;Urine Kidney Injury Molecule-1 (KIM-1) level. Timepoint: Urine KIM1 level measurement dose before Cisplatin administration , 6 h and 24 h after. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method.;Serum creatinine level. Timepoint: Serum creatinine level measurement dose before Cisplatin administration and 72 h after. Method of measurement: Jaffe method.	—

Measure

Time frame

Urine Neutrophil gelatinase-associated lipocalin (NGAL) level. Timepoint: Urine NGAL level measurement dose before Cisplatin administration , 6 h and 24 h after. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method.;Urine Kidney Injury Molecule-1 (KIM-1) level. Timepoint: Urine KIM1 level measurement dose before Cisplatin administration , 6 h and 24 h after. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method.;Serum creatinine level. Timepoint: Serum creatinine level measurement dose before Cisplatin administration and 72 h after. Method of measurement: Jaffe method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Jahangard-Rafsanjani

Tehran University of Medical Sciences

zjahangard@sina.tums.ac.ir+98 21 6658 1692

Outcome results

None listed

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