Clinical trial NCT06019520: Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity
Official title: Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Drug Toxicity
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be a two-arm study with 35 patients in each arm. After taking informed consent, a total of 70 patients will be enrolled. The patients will be enrolled by convenience nonprobability sampling technique. Then they will be randomized to the N-Acetylcysteine plus chemotherapy and chemotherapy-alone arms.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Serum creatinine of participant
timeFrame: 18 weeks
measure: Creatinine clearance of participant
timeFrame: 18 weeks
measure: Estimation of Acute kidney injury to participant
timeFrame: 18 weeks
measure: Blood urea nitrogen of participant
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Medical Oncology department, Fauji Foundation Hospital
state: Punjab
Study officials:
References: