Status:
UNKNOWN
Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity
Lead Sponsor:
Foundation University Islamabad
Conditions:
Drug Toxicity
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
Cisplatin is one of the first-line drugs used against many malignancies, such as lung cancer, head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, urothelial cancer, bladder can...
Eligibility Criteria
Inclusion
- Adult female outpatients with non-hematological malignancies (Breast, ovary and head and neck squamous cell carcinomas)
- Having Eastern Cooperative Oncology Group(ECOG) Performance Status ≤2 who had never received platinum based Chemotherapy in past and were now scheduled to receive high-dose cisplatin chemotherapy.
- Patients were required to have estimated glomerular filtration rate (GFR)(according to Cockcroft-Gault formula) ≥ 60 ml/min at start of chemotherapy regimen with normal Blood Counts, Liver, and kidney function tests
Exclusion
- Patients who had poor performance status i.e., ECOG Performance Status 3 or 4
- Who declined to participate at any time during the course of the study
- Patients having hepatic failure (Liver Function tests \>3 times of upper limit normal)
- Patients who did not tolerate the use of NAC or were administered the drug \<70% of the time
- Patient who were receiving concurrent nephrotoxic drugs, or having history of Hypersensitivity to N-Acetyl cysteine.
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 9 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06019520
Start Date
August 9 2023
End Date
March 9 2024
Last Update
August 31 2023
Active Locations (1)
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1
Medical Oncology department, Fauji Foundation Hospital
Rawalpindi, Punjab Province, Pakistan, 46000