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

NCT ID: NCT06019520

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2024-03-09

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 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.

Conditions

Drug Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cisplatin group

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

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.

N-acetylcysteine group

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.

Group Type: EXPERIMENTAL

N-Acetylcysteine

Intervention Type: DRUG

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

Intervention Type: DRUG

Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.

Interventions

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.

Intervention Type: DRUG

Chemotherapy

Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Oncology department, Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

FUI/CTR/2023/14

Identifier Type: -

Identifier Source: org_study_id