drugset / Trial / NCT06019520

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

NCT06019520

Unknown 70 enrolled Foundation University Islamabad
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2023-08-09
Primary completion
2024-02-09
Completion
2024-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 1200 mg Oral
Background Cisplatin Other / unclassified

Indications