Lymphoblastic Leukemia, Acute, ChildhoodPhase 4NCT05611086
N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia
A Phase 4 study testing N-Acetylcysteine in people with Lymphoblastic Leukemia, Acute, Childhood, run by Teny Tjitra Sari at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Lymphoblastic Leukemia, Acute, Childhood
- What is being tested?
- N-Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Aug 2019to 3 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr Cipto Mangunkusumo National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia: A Single Blind, Randomized Controlled Trial
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.
Read the detailed description
The current study has been designed as a randomized single-blind placebo-controlled clinical trial. Sample size calculation for the study was 18 newly diagnosed ALL children in each group using the numerical unpaired two groups data analysis formula. Subjects were recruited from newly diagnosed children with ALL and will start the induction phase of chemotherapy both in hospital ward and outpatient clinic in the Child Health Department at Cipto Mangunkusumo Hospital from August to December 2020. Subjects' parents received an explanation about the study, including the objective and benefits of the study, and also the procedure which will be held. Parents were then asked about the willingness to join the study and signed the form.
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. Subjects in treatment group will be given capsules containing 600 mg of NAC and subjects in the control group will be given capsules containing placebo (lactose) as the adjunctive treatment during the 6 week induction phase of chemotherapy. 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. NAC will be administered during the induction phase of chemotherapy starting in the first week until 6 weeks. This study will analyze change of MDA levels, transaminase enzyme levels, and bilirubin levels before and after the 6th week of the induction phase of chemotherapy.
- Conditions
- Lymphoblastic Leukemia, Acute, Childhood
- Being tested
- N-Acetylcysteine, Placebo
- Keywords
- Malondialdehyde, N-acetylcysteine, Oxidative stress
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
Also called Fluimucil
Subjects in treatment group will be given capsules containing 600 mg of NAC
PlaceboDrug
subjects in the control group will be given capsules containing placebo (lactose)
| Study group | Role | What they receive |
|---|---|---|
| NAC Group | Experimental | Participants of this group was given capsules containing 600mg N-acetylcysteine Receives: Drug: N-Acetylcysteine |
| Placebo | Placebo comparator | Participants of this group was given capsules containing lactose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDA (Malondialdehyde)
nanomol
Measured: Change from Baseline Malondialdehyde level at 7 week
Aspartate aminotransferase
u/L
Measured: Change from Baseline Aspartate aminotransferase level at 7 week
Alanine transaminase
u/L
Measured: Change from Baseline Alanine transaminase level at 7 week
Bilirubin
mg/dL
Measured: Change from Baseline Bilirubin level at 7 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start29 Aug 2019
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Why it stopped: The study stopped because the study period already ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic Leukemia, Acute, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teny Tjitra Sari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Teny Tjitra Sari, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Teny T Sari, Principal investigator, DR Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611086
- Sponsor's protocol ID
- 19-07-0807
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia: A Single Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05611086
- Acronym / sponsor ID
- 19-07-0807
- Conditions
- Lymphoblastic Leukemia, Acute, Childhood
- Keywords
- Malondialdehyde, N-acetylcysteine, Oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped because the study period already ended
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Teny Tjitra SariUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current study has been designed as a randomized single-blind placebo-controlled clinical trial. Sample size calculation for the study was 18 newly diagnosed ALL children in each group using the numerical unpaired two groups data analysis formula. Subjects were recruited from newly diagnosed children with ALL and will start the induction phase of chemotherapy both in hospital ward and outpatient clinic in the Child Health Department at Cipto Mangunkusumo Hospital from August to December 2020. Subjects' parents received an explanation about the study, including the objective and benefits of the study, and also the procedure which will be held. Parents were then asked about the willingness to join the study and signed the form.
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. Subjects in treatment group will be given capsules containing 600 mg of NAC and subjects in the control group will be given capsules containing placebo (lactose) as the adjunctive treatment during the 6 week induction phase of chemotherapy. 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. NAC will be administered during the induction phase of chemotherapy starting in the first week until 6 weeks. This study will analyze change of MDA levels, transaminase enzyme levels, and bilirubin levels before and after the 6th week of the induction phase of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NAC Group | Experimental | Drug: N-AcetylcysteineParticipants of this group was given capsules containing 600mg N-acetylcysteine |
| Placebo | Placebo comparator | Drug: PlaceboParticipants of this group was given capsules containing lactose |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-AcetylcysteineAlso: FluimucilSubjects in treatment group will be given capsules containing 600 mg of NAC | Drug | NAC Group |
| Placebosubjects in the control group will be given capsules containing placebo (lactose) | Drug | Placebo |
Primary outcome
MDA (Malondialdehyde)
Time frame: Change from Baseline Malondialdehyde level at 7 week
nanomol
Aspartate aminotransferase
Time frame: Change from Baseline Aspartate aminotransferase level at 7 week
u/L
Alanine transaminase
Time frame: Change from Baseline Alanine transaminase level at 7 week
u/L
Bilirubin
Time frame: Change from Baseline Bilirubin level at 7 week
mg/dL
Results and safety
The study was stopped early (reason given: The study stopped because the study period already ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Assessment of the Role of Oxidative Stress and Circulating Biochemical markers in Childhood LeukemiaLink provided by the sponsor.
- Dual effect of oxidative stress on leukemia cancer induction and treatmentLink provided by the sponsor.
- Liver Function Tests in Patients of Acute Leukemia before and after Induction ChemotherapyLink provided by the sponsor.
- Evaluation of Oxidative Stress in Patients with Acute Lymphoblastic Leukemia: Experimental Evidence of the Efficacy of MDA as Cancer Biomarker in Young PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teny T Sari principal investigator
DR Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-Acetylcysteine in people with Lymphoblastic Leukemia, Acute, Childhood, run by Teny Tjitra Sari at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study stopped because the study period already ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDA (Malondialdehyde) (time frame: Change from Baseline Malondialdehyde level at 7 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.