Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity

Drug Toxicity Clinical Trial

Official title:

Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06019520
• Other study ID #: FUI/CTR/2023/14
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: March 9, 2024

Study information

• Verified date: August 2023
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 cancer and testicular cancer. The usage of Cisplatin is limited by its severe nephrotoxicity, which particularly affects the proximal tubule epithelial cells (PTEC).Several studies suggest role of NAC in ameliorating Cisplatin induced nephrotoxicity, although definitive data is lacking. N-Acetylcysteine (NAC) is a thiol-containing antioxidant, which not only acts as a precursor of glutathione but also as a direct antioxidant .There are multiple postulated mechanisms for NAC's nephroprotection. NAC is a low-cost, easily available drug with a very good safety profile and therefore can be added as a support medication during treatment with cisplatin. The investigators plan to administer 1200 mg oral NAC 12 hours before chemotherapy and then daily at night for the subsequent 6 days, with an objective to ascertain its nephroprotective role in population receiving Cisplatin/-based chemotherapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: March 9, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions

Intervention

Drug:
• N-Acetylcysteine
Patients in the NAC arm will receive1200 mg of NAC (water-soluble granule Preparation) administered orally once daily at night for 7 consecutive days (1 days before chemotherapy, on the day of chemotherapy, and 5 days after chemotherapy) in each cycle of chemotherapy.
• Chemotherapy
Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.

Locations

Country	Name	City	State
Pakistan	Medical Oncology department, Fauji Foundation Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine of participant	Blood samples collected and measured in laboratory with the unit mg/dL	18 weeks
Primary	Creatinine clearance of participant	It will be calculated using Cockroft-Gault formula , unit ml/min	18 weeks
Primary	Estimation of Acute kidney injury to participant	Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients	18 weeks
Primary	Blood urea nitrogen of participant	Blood samples collected and measured in laboratory with the unit mg/dl	18 weeks