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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • N-acetylcysteine (NAC)

    Drug

    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.

  • Placebo

    Drug

    Patient will get placebo

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: N-AcetylcysteineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Kidney injury molecule-1

Detected from participants urine sample indicating kidney function, will be measured at baseline, and after the intervention

Time frame
1 week and 3 weeks after intervention
2

Creatinine

Creatinine will be measured from participants blood serum sample at baseline, and after intervention

Time frame
1 week and 3 weeks after intervention

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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