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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFakultas Kedokteran Universitas Indonesia

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

Qualifiers

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

Treatments tested in this trial

  • N-acetylcysteine (NAC)
  • Placebo

Treatment groups

72 Participants
are divided into 2 treatment groups

Locations

This trial has no locations