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N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia

NCT05611086 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-11-09

No results posted yet for this study

Summary

The goal of this clinical trial is to analyze the effect of N-Acetylcysteine administration towards blood oxidant level, transaminase enzyme, and bilirubin level in ALL children who undergo induction phase of chemotherapy. The main question it aims to answer is whether N-Acetylcysteine can decrease oxidative stress level and reduce hepatotoxicity complication.

Participants will be evaluated for MDA level, transaminase enzymes and bilirubin level before, during, and after the chemotherapy. Participants will be given capsules containing 600mg of N-Acetylcysteine as adjunctive treatment during the 6 weeks induction phase of chemotherapy.

Researchers will compare the lab results to the placebo group to see if there is any significant difference in the results.

Conditions

  • Lymphoblastic Leukemia, Acute, Childhood

Interventions

DRUG

N-Acetylcysteine

Subjects in treatment group will be given capsules containing 600 mg of NAC

DRUG

Placebo

subjects in the control group will be given capsules containing placebo (lactose)

Sponsors & Collaborators

  • Teny Tjitra Sari

    lead OTHER

Principal Investigators

  • Teny T Sari · DR Cipto Mangunkusumo National Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-29
Primary Completion
2020-12-03
Completion
2020-12-03

Countries

  • Indonesia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611086 on ClinicalTrials.gov