N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia

NCT05611086 | Terminated Phase 4

• 1 other identifier: 19-07-0807
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Malondialdehyde; N-acetylcysteine; Oxidative stress

Outcome Measures

Primary Outcomes (4)

• MDA (Malondialdehyde)

  nanomol

  Change from Baseline Malondialdehyde level at 7 week

• Aspartate aminotransferase

  u/L

  Change from Baseline Aspartate aminotransferase level at 7 week

• Alanine transaminase

  u/L

  Change from Baseline Alanine transaminase level at 7 week

• Bilirubin

  mg/dL

  Change from Baseline Bilirubin level at 7 week

Study Arms (2)

NAC Group

EXPERIMENTAL

Participants of this group was given capsules containing 600mg N-acetylcysteine

Drug: N-Acetylcysteine

Placebo

PLACEBO COMPARATOR

Participants of this group was given capsules containing lactose

Drug: Placebo

Interventions

N-Acetylcysteine DRUG

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

Also known as: Fluimucil

NAC Group

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Teny Tjitra Sari: lead

Study Sites (1)

Dr Cipto Mangunkusumo National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Links

• Assessment of the Role of Oxidative Stress and Circulating Biochemical markers in Childhood Leukemia
• Dual effect of oxidative stress on leukemia cancer induction and treatment
• Liver Function Tests in Patients of Acute Leukemia before and after Induction Chemotherapy
• Evaluation of Oxidative Stress in Patients with Acute Lymphoblastic Leukemia: Experimental Evidence of the Efficacy of MDA as Cancer Biomarker in Young Patients

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Teny T Sari

  DR Cipto Mangunkusumo National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both of the medicines were prepared by the Installation of Pharmacy in Cipto Mangunkusumo National Hospital with the same type and same color of capsules.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR. dr.

Model Details: Subjects were randomized consecutively and distributed into two groups. Randomization was done by a third person to decide the distribution of the subjects based on the serial number of randomization.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 9, 2022
• Study Start: August 29, 2019
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)