Acetylcysteine Adverse Reaction, Acute Kidney Injury, Cancer (Solid Tumors), Kidney Function Issue, Kidney Function Tests
Conditions
Keywords
kidney injury molecule 1, KIM-1, Creatinine, N-Acetylcysteine
Brief summary
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.
Interventions
DRUGN-acetylcysteine (NAC)
N-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.
DRUGPlacebo
Patient will get placebo
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Patients with cisplatin based chemotherapy
Exclusion criteria
* 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 * Patient with history of malignant or uncontrolled hypertension * patient with congestive heart failure, kidney structure abnormality, and acute infection * Pregnant or lactating women * Patient refusing to participate in the research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kidney injury molecule-1 | 1 week and 3 weeks after intervention | Detected from participants urine sample indicating kidney function, will be measured at baseline, and after the intervention |
| Creatinine | 1 week and 3 weeks after intervention | Creatinine will be measured from participants blood serum sample at baseline, and after intervention |
Contacts
Primary ContactOryza G Prabu, MD, Specialist
Backup ContactPringgodigdo Nugroho, MD, Doctor
Outcome results
None listed