TerminatedPhase 4

N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia

Stopped: The study stopped because the study period already ended

Indonesia16 participantsStarted 2019-08-29

Plain-language 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.

Who can participate

Age range

1 Year – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * newly diagnosed ALL-Standard Risk children who will undergo the induction phase of chemotherapy from 1st week until 6th week * parents agreed to participate in the study and signed the informed consent Exclusion Criteria: * subjects with allergy or contraindicated to consuming N-acetylcysteine * subjects with liver dysfunction based on clinical and laboratory tests diagnosed before joining the study * subjects who already consume other antioxidants (vitamin A, vitamin C, and vitamin E).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MDA (Malondialdehyde)

Timeframe: Change from Baseline Malondialdehyde level at 7 week

Aspartate aminotransferase

Timeframe: Change from Baseline Aspartate aminotransferase level at 7 week

Alanine transaminase

Timeframe: Change from Baseline Alanine transaminase level at 7 week

Bilirubin

Timeframe: Change from Baseline Bilirubin level at 7 week

Trial details

NCT IDNCT05611086

SponsorTeny Tjitra Sari

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-03

View on ClinicalTrials.gov More Lymphoblastic Leukemia, Acute, Childhood trials