About this trial
The goal of this clinical trial is to learn if N-Acetylcysteine drug works to protect kidney function in adults patient with cancer. Kidney function will be measured by laboratory parameter using urine sample (KIM-1 urine) and blood sample (serum creatinine). The main questions it aims to answer are:
1. Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection? 2. Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection?
Participants will:
1. Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo) 2. Underwent cisplatin based chemotherapy 3. Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy) 4. Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy) 5. Had their symptoms monitor during and after taking the drugs. Every possible side effect, hospitalization, or death will be recorded.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with cancer/ malignancy proven by histopathological examination
Patient with GFR ≥60 ml/mins/1,73 m²
Patient with normal complete blood count and liver function test result
Patient with good performance status (Karnofsky score ≥80)
Disqualifiers
Patient that can not tolerate N-Acetylcysteine usage
Patient with history of hypersensitivity to N-Acetylcysteine
Patient that given other potentially nephrotoxic drug, such as furosemide, non-steroidal anti-infammatory drugs, aminoglycosides, amphotericin B, cephalosporine
Patient that given other chemotherapy drug, such as permetrexed, ifosfamide, gemcitabin, bevacizumab, cetuxsimab
Trial design
Parallel
Treatments tested in this trial
N-acetylcysteine (NAC)
DrugN-Acetylcysteine effercescent 1200 mg orally twice a day for 7 days. One day before cisplatin based chemotherapy, on the chemotherapy day, and five days after.
Placebo
DrugPatient will get placebo
Treatment groups
Trial outcomes
Primary outcomes
Kidney injury molecule-1
Detected from participants urine sample indicating kidney function, will be measured at baseline, and after the intervention
Creatinine
Creatinine will be measured from participants blood serum sample at baseline, and after intervention
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: