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Study to Evaluate the Effect of Aprepitant in Children and Adolescents Receiving AML Remission Induction Chemotherapy

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ClinicalTrials.gov Identifier: NCT02979548
Recruitment Status : Unknown
Verified January 2017 by Dr Atul Sharma, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : December 1, 2016
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Atul Sharma, All India Institute of Medical Sciences, New Delhi

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Chemotherapy Induced Vomiting Acute Myeloid Leukemia Drug: Aprepitant Drug: Ondansetron Drug: Metoclopramide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : November 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Group A : Aprepitant (Add on therapy)
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.
Drug: Aprepitant
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.
Other Name: Apretero

Drug: Ondansetron
Ondansetron is 5HT3 Receptor antagonist used to treat and prevent chemotherapy induced nausea and vomiting
Other Name: Zofer, Emset

Drug: Metoclopramide
Dopamine receptor antagonist , acts at CTZ. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.
Other Name: Reglan

Active Comparator: Group B : 5HT3 RA (Ondansetron)

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.

Drug: Ondansetron
Ondansetron is 5HT3 Receptor antagonist used to treat and prevent chemotherapy induced nausea and vomiting
Other Name: Zofer, Emset

Drug: Metoclopramide
Dopamine receptor antagonist , acts at CTZ. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.
Other Name: Reglan




Primary Outcome Measures :
  1. Proportion of patients with complete response during the acute phase of AML remission induction chemotherapy [ Time Frame: Up to day 8 of induction ]

Secondary Outcome Measures :
  1. Time to first episode of vomiting [ Time Frame: Up to day 13 ]
  2. Incidence of delayed vomiting [ Time Frame: From day 9 to day 13 ]
  3. Severity of vomiting [ Time Frame: Up to day 13 ]
    Severity will be assessed by NCI CTCAE Criteria version 4.0

  4. Incidence of requirement of rescue medication [ Time Frame: Up to day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979548


Contacts
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Contact: Atul Sharma, M.D +91-9968859779 dratulsharma@hotmail.com

Locations
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India
Irch, Aiims , New Delhi , India Recruiting
New Delhi, DEL, India, 110029
Contact: ATUL SHARMA, MD    9968859779    dratulsharma@hotmail.com   
Sponsors and Collaborators
Dr Atul Sharma
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Atul Sharma, Senior Resident, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02979548    
Other Study ID Numbers: IECPG-419
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is undecided but if required the data can be made available.
Keywords provided by Dr Atul Sharma, All India Institute of Medical Sciences, New Delhi:
Aprepitant
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Ondansetron
Aprepitant
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Neurokinin-1 Receptor Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents