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CTRI Number  CTRI/2025/01/079577 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How Safe and Effective Are Fosaprepitant and Aprepitant in Reducing Nausea and Vomiting in Children with Cancer Undergoing Chemotherapy 
Scientific Title of Study   A study of efficacy and safety of intravenous Fos aprepitant versus oral Aprepitant in prevention of chemotherapy induced nausea and vomiting in children a randomized controlled 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  SRIDEVI R 
Designation  Senior Resident  
Affiliation  Kidwai Memorial Institute Of Oncology  
Address  dept of pediatric oncology Kidwai memorial institute of oncology Dr MH, Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru, Karnataka
Dr MH , Marigowda Road, Hombegowda nagar , Bengaluru , Karnatka 560029
Bangalore
KARNATAKA
560029
India 
Phone  9003288736  
Fax    
Email  sridevi199425@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ARUN KUMAR A R 
Designation  PROFESSOR AND HOD PEDIATRIC ONCOLOGY 
Affiliation  Kidwai Memorial Institute Of Oncology  
Address  dept of pediatric oncology Kidwai memorial institute of oncology Dr MH, Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru, Karnataka
Dr MH , Marigowda Road, Hombegowda nagar , Bengaluru , Karnatka 560029
Bangalore
KARNATAKA
560029
India 
Phone  9740612324  
Fax    
Email  dr.arun123@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  SRIDEVI R 
Designation  Senior Resident  
Affiliation  Kidwai Memorial Institute Of Oncology  
Address  dept of pediatric oncology Kidwai memorial institute of oncology Dr MH, Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru, Karnataka
Dr MH , Marigowda Road, Hombegowda nagar , Bengaluru , Karnatka 560029
Bangalore
KARNATAKA
560029
India 
Phone  9003288736  
Fax    
Email  sridevi199425@gmail.com  
 
Source of Monetary or Material Support  
Department of pediatric oncology Kidwai memorial institute of oncology Dr MH, Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru, Karnataka . 560029 INDIA 
 
Primary Sponsor  
Name  SRIDEVI R 
Address  208, manish classic apartments , ranka colony road , bilekehalli , bengaluru Karnataka 560076 
Type of Sponsor  Other [principal investigator] 
 
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 
SRIDEVI R  Kidwai Memorial Institute of Oncology  dept of pediatric oncology Dr MH marigowda road , Hombegowda nagar , Bengaluru karnatka
Bangalore
KARNATAKA 		 9003288736

sridevi199425@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Ethics Committee - Kidwai Memorial Institute of Oncology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R110||Nausea, (2) ICD-10 Condition: R111||Vomiting,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  capsule aprepitant   Capsule aprepitant is an oral formulation of NK1 receptor antagonist approved for use in pediatric and adults for prevention of chemotherapy induced nausea and vomiting .Dosage of aprepitant is weight based (15 to 40 kg: days 1 to 3, 80 mg; 41 to 65 kg on day 1 125 mg; and days 2 and 3 80 mg)In this study patients enrolled in Arm B will receive oral aprepitant plus dexamethasone plus ondansetron 
Intervention  injection fosaprepitant   Injection fosaprepitant is an intravenous preparation of NK receptor antagonist approved for use in prevention of nausea and vomiting in children and adults receiving highly emetogenic chemotherapy .It is given at a dose of 4mg per kg (max 150 mg )intravenous infusion. In this study patients enrolled in arm A of the study will receive injection fosaprepitant plus dexamethasone plus ondansetron  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children aged between 4 to 15 years diagnosed with malignancy, who are treated with first cycle highly emetogenic chemotherapy (as per Pediatric
Oncology Group of Ontario POGO clinical practice guidelines endorsed by Childrens Oncology Group COG supportive care guidelines taskforce) and
weighing more than 15 kg . 
 
ExclusionCriteria 
Details  1.Preexisting vomiting within 48 hours prior to chemotherapy due to any cause.
2.Children allergic to 5HT3 antagonists ,aprepitant and Fosaprepitant.
3.Patients with congestive cardiac failure or QT prolongation .
4.Deranged renal (creatinine more than upper limit of normal for age ) or hepatic function (transaminases 3 times upper limit of normal and or bilirubin 1.5 times upper limit of normal ).
5.Recent radiation therapy to abdomen or pelvis in the previous 1 week .
6.Primary or metastatic central nervous system malignancy causing raised intracranial pressure. 7.Patients started on systemic corticosteroid therapy 72 hours prior to study drug administration or planned to receive corticosteroid as part of therapy.
8.Patients on warfarin, itraconazole, everolimus, clarithromycin, phenytoin, rifampicin, carbamazepine, antiHIV therapy or
ketoconazole.
9.Patients initiated on opioids within 48 hours of study enrollment and treatment.
10.Patients refusing consent or not willing for followup 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the complete response (defined as absence of retching, vomiting /use
of rescue medications) rate during the acute phase (0-24 hours within
administration of chemotherapy) in both arms of the study( Arm A Fosaprepitant
plus dexamethasone plus ondansetron , Arm B :aprepitant plus dexamethasone
plus ondansetron) .

 		 acute phase (0-24 hours within
administration of chemotherapy) in both arms of the study
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the patients who achieved complete response in delayed phase
24-120 hours after administration of last dose of chemotherapy in both arms of the
study
2.To determine the patients who achieved overall complete response during the
chemotherapy cycle.in both arms of the study
3.Percentage of patients requiring rescue anti-emetics. chemotherapy in both
arms of the study
4.To determine the adverse effects associated with aprepitant and fosaprepitant
usage. 		 delayed phase
24-120 hours after administration of last dose of chemotherapy in both arms of the
study 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   30/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Chemotherapy induced nausea and vomiting (CINV) is one of the most feared side effects of cancer treatment . It affects 70% of pediatric patients
undergoing cancer chemotherapy. Effective management of CINV is critical in children as they are often more vulnerable to both the immediate discomfort of nausea and vomiting and the long-term impacts, including malnutrition, dehydration, and psychological distress.
There is paucity of data related to usage of fosaprepitant and oral aprepitant in pediatric oncology patients. This study aims to determine the
efficacy and safety of intravenous fosparepitant versus oral aprepitant in prevention of CINV in pediatric oncology patients . Following are the advantages of fosaprepitant over aprepitant
1. Single dose administration ensures compliance and ease of administration .There is reduced chances of missed doses if patients are treated on outpatient basis.
2. It is beneficial in those children who have difficulty in swallowing capsules or who vomit out capsules in the peri-chemotherapy period .As of now , Aprepitant is available only as as capsules in India .
3. With regard to weight-based dosing, fosaprepitant can be more precisely dosed when compared to aprepitant capsules in children .

The patient data will be collected on a predesigned proforma. Chemo-naive patients planned for 1 st cycle of chemotherapy will be enrolled
in the study .They will be randomly assigned to intervention arm A or arm B by computer generated randomization blocks. The randomization blocks
which will be with an individual not involved in study enrolment, administration of intervention, data collection or data analysis. The intervention arm A will receive fosaprepitant plus dexamethasone plus ondansetron and Arm B will receive aprepitant plus dexamethasone plus ondansetron. All the enrolled patients will be followed up for a period of 0- 120 hours from the last administered chemotherapy dose . The caregivers or parents
shall be asked to maintain a diary mentioning the number of events of vomiting and nausea along with time , feeds and fluids taken orally. PeNat visual assessment tool (Kannada translation) will be used to report the number of nausea events in a day (after validation in pilot population).
Absence of vomiting or retching, need for rescue medications during the specified period will be taken as complete response to therapy and presence
of vomiting , retching and need for rescue medications during the specified period will be considered as partial response to therapy. The results will be analyzed by R4.4.1. Analysis will be done on Intention to treat basis. Comparison between categorical variables will be done by chi-square test, proportions are compared with Z test and continuous variables will be compared by Student’s t test. A significance level of 0.05 will be used. 
 
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