Evaluation of nephroprotective effects of Melatoni

Phase 3

Recruiting

• Conditions: C7, C8 ,; ung? 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

• Registration Number: IRCT20171225038073N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 September 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rine 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.