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

University of Indonesia (UI)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Cancer (Solid Tumors); Acute Kidney Injury; Acetylcysteine Adverse Reaction; Kidney Function Tests; Kidney Function Issue

Treatments: Drug: Placebo; Drug: N-acetylcysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07156786

25-02-0179

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patient receiving placebo and cisplatin chemotherapy

Treatment:

Drug: Placebo

N-Acetylcysteine

Experimental group

Description:

Patient receiving NAC + cisplatin based chemotherapy

Treatment:

Drug: N-acetylcysteine (NAC)