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 3Not Yet RecruitingNCT07156786

Fakultas Kedokteran Universitas Indonesia72 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Kidney Function Issue Acute Kidney Injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Creatinine

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