Clinical trial · Interventional
N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creatinine on Cancer Patients With Cisplatin Based Chemotherapy: A Randomized Placebo-Controlled Trial
N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acetylcysteine Adverse Reaction | — | UNRESOLVED | — |
| Acute Kidney Injury | — | UNRESOLVED | — |
| Cancer (Solid Tumors) | Malignant Neoplasm | ALIAS | 0.85 |
| Kidney Function Issue | — | UNRESOLVED | — |
| Kidney Function Tests | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-acetylcysteine (NAC) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patient receiving placebo and cisplatin chemotherapy
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- N-Acetylcysteine
- description
- Patient receiving NAC + cisplatin based chemotherapy
- interventionNames
- Drug: N-acetylcysteine (NAC)
Primary outcomes (2)
- measure
- Kidney injury molecule-1
- timeFrame
- 1 week and 3 weeks after intervention
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available