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Not yet recruiting NCT07156786

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

Phase II / Phase III Interventional Kidney Function Issue Acute Kidney Injury Cancer (Solid Tumors) Kidney Function Tests

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N-acetylcysteine (NAC), Placebo.
Who it may be relevant to
Registry conditions: Kidney Function Issue, Acute Kidney Injury, Cancer (Solid Tumors), Kidney Function Tests. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy

Overview

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

  • Drug N-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.
  • Drug Placebo
    Patient will get placebo

Primary outcome measures

  • Kidney injury molecule-1 [Time frame: 1 week and 3 weeks after intervention]
  • Creatinine [Time frame: 1 week and 3 weeks after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07156786 · 25-02-0179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗