N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia

• Status: Terminated
• Trial end date: 2020-12-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teny Tjitra Sari
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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).