Clinical trial · Interventional
Study to Evaluate the Effect of Aprepitant in Children and Adolescents Receiving AML Remission Induction Chemotherapy
Study to Evaluate the Anti-emetic Effect of Aprepitant as an add-on Therapy in Children and Adolescents Receiving AML Remission Induction Chemotherapy: An Investigator-initiated, Randomized, Open Label Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to find out the efficacy of an anti-emetic drug, Aprepitant as an add-on therapy to prevent vomiting in children and adolescents receiving chemotherapy for leukemia (AML). Children and adolescents admitted with confirmed diagnosis of AML will be assessed for eligibility criteria and enrolled in the study. Then they will be divided (randomized) into experimental and control groups. Experimental group will receive Aprepitant capsules 1 h prior to chemotherapy on days 1-3 in addition to ondansetron. Patients will be required to swallow the whole capsule and opening of capsule will not be permitted. All three doses will be administered under supervision. Control group will receive ondansetron (0.15 mg/kg) as an intravenous bolus 30 minutes before chemotherapy followed by every 8 hourly for 8 days. Metoclopramide will be used as a rescue agent. The data will be collected from each patient in a proforma from day 1 to day 13 of chemotherapy. A Diary will be maintained for nausea and vomiting record. Edmonton's symptom assessment criterion will be used in the diary for assessing severity of nausea. The NCI guidelines will be used to assess the severity of vomiting based on the data provided by the patient in the diary. A modified intention-to-treat population (patients who receive chemotherapy, take one or more doses of study drug, and have one or more post treatment measurements) will be used for efficacy analysis. Proportion of patients with complete response will be compared between patients with or without aprepitant.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chemotherapy Induced Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant | Drug | — | UNRESOLVED |
| Metoclopramide | Drug | — | UNRESOLVED |
| Ondansetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A : Aprepitant (Add on therapy)
- description
- Aprepitant group will receive aprepitant capsules 1 h prior to chemotherapy on days 1-3 in addition to 5HT3 RA (Ondansetron). The dose of aprepitant will be given based on weight groups Weight 15-40 kg : Aprepitant 80 mg on days 1-3 Weight \> 41kg: Aprepitant 125 mg on day 1 followed by 80 mg on days 2-3 Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.
- interventionNames
- Drug: Aprepitant
- Drug: Ondansetron
- Drug: Metoclopramide
- type
- ACTIVE_COMPARATOR
- label
- Group B : 5HT3 RA (Ondansetron)
- description
- On the day of chemotherapy, ondansetron will be administered to all patients as per our institutional practice in a dose of 0.15 mg/kg as an intravenous bolus 30 minutes before chemotherapy followed by every 8 hourly for 8 days. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.
- interventionNames
- Drug: Ondansetron
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed, chemotherapy-naïve de novo AML patients planned for 3+7 remission induction chemotherapy in the age group 5-18 years 2. Weight above 15 kg (Those who are able to swallow the medication ) 3. Children/adolescents and their caregiver who can understand Hindi or English and willing to participate in the study (with written informed consent) Exclusion Criteria: 1. Vomiting/retching within 24 h prior to treatment 2. Significant organ dysfunction (aspartate aminotransferase/alanine aminotransferase \>2.5 times of upper normal limit, serum bilirubin \>1.5 times of upper normal limit, serum creatinine\>1.5 times of upper normal limit) 3. Patient on inotropic support at presentation 4. Patient with respiratory failure/mechanical ventilation at presentation
References
Publications (1)
- DERIVEDSharma A, Ganguly S, C SK, Pillai AS, Dhawan D, Sreenivas V, Bakhshi S. Addition of aprepitant improves acute emesis control in children and adolescents receiving induction chemotherapy for acute myeloid leukaemia: a randomised, open-label trial. BMJ Support Palliat Care. 2023 Oct;13(e1):e156-e162. doi: 10.1136/bmjspcare-2020-002595. Epub 2020 Oct 29. PMID 33122168