Chemotherapy Induced VomitingPhase 3NCT02979548
Study to Evaluate the Effect of Aprepitant in Children and Adolescents Receiving AML Remission Induction Chemotherapy
A Phase 3 study testing Aprepitant, Ondansetron and Metoclopramide in people with Chemotherapy Induced Vomiting and Acute Myeloid Leukemia, run by Dr Atul Sharma at 1 site in India.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Chemotherapy Induced Vomiting, Acute Myeloid Leukemia
- What is being tested?
- Aprepitant, Ondansetron and Metoclopramide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2016to Dec 2018
- Phase
- Phase 3
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed, chemotherapy-naïve de novo AML patients planned for 3+7 remission induction chemotherapy in the age group 5-18 years
- Weight above 15 kg (Those who are able to swallow the medication )
- Children/adolescents and their caregiver who can understand Hindi or English and willing to participate in the study (with written informed consent)
Who cannot join
- Vomiting/retching within 24 h prior to treatment
- 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)
- Patient on inotropic support at presentation
- Patient with respiratory failure/mechanical ventilation at presentation
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Irch, Aiims , New Delhi , India
New Delhi, DEL, 110029
ATUL SHARMA, MD, 9968859779, dratulsharma@hotmail.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Children and adolescents admitted with confirmed diagnosis of AML will be assessed for eligibility criteria and enrolled in the study. Subjects will be randomized into experimental and control groups using table of random numbers generated by computer.Experimental group will receive aprepitant capsules as an add-on therapy (Apretero; Hetero Laboratories, India) 1 h prior to chemotherapy on days 1-3 in addition to ondansetron.
The dose of aprepitant will be as per our previous study 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 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 by the sister allocated. Control group will receive ondansetron (0.15 mg/kg) as an intravenous bolus 30 minutes before chemotherapy followed by every 8 hourly. 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 by the investigator during his/her stay as in-patient in the hospital. The Proforma will contain different items dealing with demographic and clinical characteristic of the subjects.A Diary will be maintained for nausea and vomiting record. It will help in collecting data regarding nausea, vomiting along with some additional variables like- chemotherapy related toxicities, requirement of any rescue medication.
The subjects will be given the diary for symptom assessment on day 1 and it will be filled up under the supervision of the investigator on day 1 and day 2 of chemotherapy. The diary will be given to the subjects on day 3 of the chemotherapy to record all the events (incidence and severity of nausea, vomiting, requirement of rescue medication and other toxicities).
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.Patients/attendant's will be explained about the filling of the diary and will maintain it for recording of vomiting under the investigator's supervision.
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 CR will be compared between patients with or without aprepitant.
- Being tested
- Aprepitant, Ondansetron, Metoclopramide
- Keywords
- Aprepitant
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Apretero
Aprepitant is a non peptide, selective, Neurokinin type 1 (NK 1) receptor antagonist. Group A will receive Aprepitant as an add-on anti-emetic therapy in addition to ondansetron.
OndansetronDrug
Also called Zofer, Emset
Ondansetron is 5HT3 Receptor antagonist used to treat and prevent chemotherapy induced nausea and vomiting
MetoclopramideDrug
Also called Reglan
Dopamine receptor antagonist , acts at CTZ. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.
| Study group | Role | What they receive |
|---|---|---|
| Group A : Aprepitant (Add on therapy) | Experimental | 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. Receives: Drug: Aprepitant; Drug: Ondansetron; Drug: Metoclopramide |
| Group B : 5HT3 RA (Ondansetron) | Active comparator | 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. Receives: Drug: Ondansetron; Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete response during the acute phase of AML remission induction chemotherapy
Measured: Up to day 8 of induction
Secondary outcomes (4)
Time to first episode of vomiting
Measured: Up to day 13
Incidence of delayed vomiting
Measured: From day 9 to day 13
Severity of vomiting
Severity will be assessed by NCI CTCAE Criteria version 4.0
Measured: Up to day 13
Incidence of requirement of rescue medication
Measured: Up to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced VomitingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Atul Sharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Atul Sharma, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979548
- Sponsor's protocol ID
- IECPG-419
- Status last verified
- Jan 2017
- First submitted
- 28 Nov 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: It is undecided but if required the data can be made available.
Publications
Sharma 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.
PubMed 33122168
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02979548
- Acronym / sponsor ID
- IECPG-419
- Keywords
- Aprepitant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Dr Atul SharmaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- 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 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.
Detailed description
Children and adolescents admitted with confirmed diagnosis of AML will be assessed for eligibility criteria and enrolled in the study. Subjects will be randomized into experimental and control groups using table of random numbers generated by computer.Experimental group will receive aprepitant capsules as an add-on therapy (Apretero; Hetero Laboratories, India) 1 h prior to chemotherapy on days 1-3 in addition to ondansetron.
The dose of aprepitant will be as per our previous study 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 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 by the sister allocated. Control group will receive ondansetron (0.15 mg/kg) as an intravenous bolus 30 minutes before chemotherapy followed by every 8 hourly. 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 by the investigator during his/her stay as in-patient in the hospital. The Proforma will contain different items dealing with demographic and clinical characteristic of the subjects.A Diary will be maintained for nausea and vomiting record. It will help in collecting data regarding nausea, vomiting along with some additional variables like- chemotherapy related toxicities, requirement of any rescue medication.
The subjects will be given the diary for symptom assessment on day 1 and it will be filled up under the supervision of the investigator on day 1 and day 2 of chemotherapy. The diary will be given to the subjects on day 3 of the chemotherapy to record all the events (incidence and severity of nausea, vomiting, requirement of rescue medication and other toxicities).
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.Patients/attendant's will be explained about the filling of the diary and will maintain it for recording of vomiting under the investigator's supervision.
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 CR will be compared between patients with or without aprepitant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Aprepitant (Add on therapy) | Experimental | Drug: Aprepitant, Drug: Ondansetron, Drug: MetoclopramideAprepitant 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. |
| Group B : 5HT3 RA (Ondansetron) | Active comparator | Drug: Ondansetron, Drug: MetoclopramideOn 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Newly diagnosed, chemotherapy-naïve de novo AML patients planned for 3+7 remission induction chemotherapy in the age group 5-18 years
- Weight above 15 kg (Those who are able to swallow the medication )
- Children/adolescents and their caregiver who can understand Hindi or English and willing to participate in the study (with written informed consent)
Key exclusion criteria (4 listed)
- Vomiting/retching within 24 h prior to treatment
- 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)
- Patient on inotropic support at presentation
- Patient with respiratory failure/mechanical ventilation at presentation
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 |
|---|---|---|
| AprepitantAlso: ApreteroAprepitant is a non peptide, selective, Neurokinin type 1 (NK 1) receptor antagonist. Group A will receive Aprepitant as an add-on anti-emetic therapy in addition to ondansetron. | Drug | Group A : Aprepitant (Add on therapy) |
| OndansetronAlso: Zofer, EmsetOndansetron is 5HT3 Receptor antagonist used to treat and prevent chemotherapy induced nausea and vomiting | Drug | Group A : Aprepitant (Add on therapy), Group B : 5HT3 RA (Ondansetron) |
| MetoclopramideAlso: ReglanDopamine receptor antagonist , acts at CTZ. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day. | Drug | Group A : Aprepitant (Add on therapy), Group B : 5HT3 RA (Ondansetron) |
Primary outcome
Proportion of patients with complete response during the acute phase of AML remission induction chemotherapy
Time frame: Up to day 8 of induction
4 secondary outcomes
Time to first episode of vomiting
Time frame: Up to day 13
Incidence of delayed vomiting
Time frame: From day 9 to day 13
Severity of vomiting
Time frame: Up to day 13
Incidence of requirement of rescue medication
Time frame: Up to day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Derived from this study: PubMed 33122168Sharma 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.
- Individual participant dataSharing planned: Undecided. It is undecided but if required the data can be made available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant, Ondansetron and Metoclopramide in people with Chemotherapy Induced Vomiting and Acute Myeloid Leukemia, run by Dr Atul Sharma at 1 site in India.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jan 2017. 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 India. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atul Sharma, M.D (+91-9968859779, dratulsharma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete response during the acute phase of AML remission induction chemotherapy (time frame: Up to day 8 of induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979548, which also lists 1 linked publication.
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 25 Jan 2017.