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

Foundation University Islamabad

Status: Active, not recruiting

Conditions: Drug Toxicity

Treatments: Drug: N-Acetylcysteine; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06019520

FUI/CTR/2023/14

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Cisplatin group

Active Comparator group

Description:

This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol

Treatment:

Drug: Chemotherapy

N-acetylcysteine group

Experimental group

Description:

Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given.

Treatment:

Drug: Chemotherapy

Drug: N-Acetylcysteine