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CTRI Number  CTRI/2024/08/072292 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare efficacy of olanzapine versus aprepitant for preventing chemotherapy induced nausea and vomiting in children with cancer 
Scientific Title of Study   Olanzapine versus Aprepitant for prevention of chemotherapy induced nausea and vomiting in children receiving highly emetogenic chemotherapy: A Randomized Open Label Trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikita Jakhar 
Designation  Senior Resident, DM Pediatric Oncology 
Affiliation  AIIMS Delhi 
Address  Mother and Child block Department of Pediatrics Division of Pediatric Oncology AIIMS Delhi Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East New Delhi

New Delhi
DELHI
110029
India 
Phone  9950646915  
Fax    
Email  nikitajakhar28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagdish Prasad Meena 
Designation  Additional Professor and Guide 
Affiliation  AIIMS Delhi 
Address  Room No. 832 8th Floor Mother and Child Block Department of Pediatrics Division of Pediatric Oncology AIIMS Delhi Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East New Delhi

New Delhi
DELHI
110029
India 
Phone  8890139358  
Fax    
Email  drjpmeena@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jagdish Prasad Meena 
Designation  Additional Professor and Guide 
Affiliation  AIIMS Delhi 
Address  Room No. 832 8th Floor Mother and Child Block Department of Pediatrics Division of Pediatric Oncology AIIMS Delhi Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East New Delhi

New Delhi
DELHI
110029
India 
Phone  8890139358  
Fax    
Email  drjpmeena@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Delhi Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East New Delhi Delhi PIN: 110029 India 
 
Primary Sponsor  
Name  Dr Nikita Jakhar 
Address  Mother and Child block Department of Pediatrics Division of Pediatric Oncology AIIMS Delhi Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East New Delhi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikita Jakhar  AIl India Institute of Medical Sciences, Delhi  Pediatric Daycare Ground Floor and Ward 5A on Fifth Floor Department of Pediatrics Division of Pediatric Oncology Mother and Child Block Opposite New OPD Rajkumari Amrit Kaur Siva Rd, Block D2, Ansari Nagar East New Delhi Delhi 110029 Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East New Delhi
New Delhi
DELHI 		 9950646915

nikitajakhar28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Committee AIIMS Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aprepitant  Oral Aprepitant dose as per weight-based regimen once a day for 3 days. For weight a. less than 15kg - 40mg orally once daily for 3 days b. 15 to 40kg - 80 mg orally once daily for 3 days c. more than 40kg - 125mg orally once on day 1 followed by 80mg once daily on day 2 and day 3  
Intervention  Olanzapine  Oral olanzapine once a day at dose 0.14mg/kg rounded to nearest multiple of 2.5mg upto maximum of 10mg. To be given on days of chemotherapy and for 3 more days post chemotherapy block completion. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Confirmed diagnosis of malignancy
2. Scheduled for highly emetogenic chemotherapy
3. Should be able to swallow the drug
4. Written informed consent 
 
ExclusionCriteria 
Details  1. Have had treatment within 14 days prior to study enrolment with olanzapine or 30 days prior with another antipsychotic agent
2.Planned to receive quinolone antibiotics or other antipsychotic agents, citalopram, amifostine, CYP1A2 inducers or inhibitors
3. History of seizure disorder
4. History of hypersensitivity to olanzapine
5. Vomited in the prior 24 hours to first dose of chemotherapy
6.Abnormal lab values (absolute neutrophil count less than 1000/mm3, total leucocyte count less than 3000/mm3, platelet count less than 100,000mm3, AST/ALT more than 2.5 times of upper limit of normal, total serum bilirubin more than 1.5 times of upper limit of normal and serum creatinine more than 1.5 times of upper limit of normal)
7. Steroids within 24 hours prior to enrolment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of olanzapine versus aprepitant when combined with ondansetron and dexamethasone in control of chemotherapy induced vomiting for the acute period   Upto 24 hours after completion of the chemotherapy block  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare between the study and control groups the efficacy of control in chemotherapy induced vomiting for delayed and overall period  Upto 120 hours after completion of the chemotherapy block 
2.To compare between the study and control groups the no nausea rates for acute, delayed and overall period  Upto 120 hours after completion of the chemotherapy block 
3.To compare between the study and control groups the need for rescue antiemetic medications  Upto 120 hours after completion of the chemotherapy block 
4. To compare between the study and control groups the need for hospital visits  Upto 120 hours after completion of the chemotherapy block 
5.To compare between the study and control groups the incidence of adverse events  Upto the scheduled next cycle of chemotherapy 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   23/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drjpmeena@gmail.com].

  6. For how long will this data be available start date provided 31-07-2027 and end date provided 31-07-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Chemotherapy induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. In current practice, pediatric patients receiving highly emetogenic chemotherapy are recommended to receive triple regimen prophylaxis with Neurokinin 1 receptor antagonist, dexamethasone and 5 HT3 receptor antagonist for prevention of CINV. Compared to aprepitant the cost and drug interaction profile of olanzapine is minimal with equivalent efficacy for CINV control as noted in adult population studies. Recent research establishes safety and efficacy of olanzapine for CINV control in pediatric population. To the best of our knowledge, there are no prospective studies in children comparing the efficacy of olanzapine versus aprepitant for CINV prophylaxis.
Thus, our research hypothesis is that among pediatric patients with cancer 3 to 18 years age who receive highly emetogenic chemotherapy, olanzapine combined with dexamethasone and ondansetron is non inferior as compared to aprepitant with dexamethasone and ondansetron for chemotherapy induced nausea and vomiting control. This would provide us with a cheaper alternative and comparable efficacy in CINV prophylaxis.
This will be a randomized, open label non inferiority trial to be conducted at Department of Pediatrics, AIIMS Delhi for a period of 2 years from July 2024 to July 2026. The primary objective will be to compare between study and control groups the complete response rates for vomiting in the acute period ( upto 24 hours after chemotherapy block completion). The secondary objectives will be to compare between the study and control groups the complete response rates for vomiting in delayed and overall period ( upto 120 hours after chemotherapy block completion), the no nausea rates, the need of rescue antiemetics and hospital visits and the incidence of adverse events.

 
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