| CTRI Number |
CTRI/2020/06/025872 [Registered on: 15/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of effectiveness of Fosaprepitant in PREVENTION of vomiting caused by cancer medication
IN children aged 1 to 12 years. |
|
Scientific Title of Study
|
An Investigator Initiated, Open Label, Prospective Study To Evaluate
Effectiveness of Fosaprepitant IV In Prevention Of Chemotherapy Induced Vomiting In Pediatric
Patients: Fosaped Trial. |
| Trial Acronym |
FOSAPED
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Hiren Trivedi |
| Designation |
Pediatric Hemato - Oncologist |
| Affiliation |
Hemato Oncology Clinic |
| Address |
Department of Hematology Hemato Oncology Clinic Ahmedabad Pvt. Ltd
Vedanta Institute of Medical Science, Nr. Samved Hospital, Stadium Commerce College Road Navrangpura Ahmedabad-380009, Gujarat India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7600598812 |
| Fax |
|
| Email |
deepahiren@Yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Hiren Trivedi |
| Designation |
Pediatric Hemato - Oncologist |
| Affiliation |
Hemato Oncology Clinic |
| Address |
Department of Hematology Hemato Oncology Clinic Ahmedabad Pvt. Ltd
Vedanta Institute of Medical Science, Nr. Samved Hospital, Stadium Commerce College Road Navrangpura Ahmedabad-380009, Gujarat India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7600598812 |
| Fax |
|
| Email |
deepahiren@Yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Hiren Trivedi |
| Designation |
Pediatric Hemato - Oncologist |
| Affiliation |
Hemato Oncology Clinic |
| Address |
Department of Hematology Hemato Oncology Clinic Ahmedabad Pvt. Ltd
Vedanta Institute of Medical Science, Nr. Samved Hospital, Stadium Commerce College Road Navrangpura Ahmedabad-380009, Gujarat India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7600598812 |
| Fax |
|
| Email |
deepahiren@Yahoo.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Limited
Glenmark House BD Sawant Marg Andheri East Mumbai
400099 |
|
|
Primary Sponsor
|
| Name |
Hemato Oncology Clinic |
| Address |
First floor, Vedanta Institute of Medical Science, Nr. Samved Hospital, Stadium Commerce College Road, Navrangpura, Ahmedabad-380009, Gujarat, India. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepa Hiren Trivedi |
Hemato Oncology Clinic |
First floor, "Vedanta" Institute of Medical Science, Nr. Samved Hospital, Stadium Commerce College Road, Navrangpura, Ahmedabad-380009, Gujarat, India.
Ahmadabad
GUJARAT |
7600598812
deepahiren@Yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Care Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R111||Vomiting, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fosaprepitant 3mg/kg
Palnosteron 0.02mg/kg
Dexamethasone 0.15mg/kg |
Patient randomized to fosaprepitant arm will receive foraprepitant 3mg/kg (maxium 150mg) as a short IV infusion in 100 ml normal saline over 30minutes. |
| Comparator Agent |
Normal Saline (Placebo) Palonosetron 0.02mg/kg
Dexamethasone 0.15mg/kg |
Patients randomized to the placebo arm will receive 100 ml normal saline as a placebo over 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 1 to 12 years
Patients with Histologically or cytological confirmed tumors
Patient naïve to chemotherapy.
Scheduled to receive their first course of chemotherapy (HEC/MEC) for treatment of a solid malignant tumor.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Predicted life expectancy of at least 3 months
Willing to provide written informed consent by parent or guardian and oral assent by patient. |
|
| ExclusionCriteria |
| Details |
Radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5.
Bone marrow or stem-cell transplant.
Vomiting, retching, or more than mild nausea within 24 hours before day 1
Children with allergy to NK-1 antagonists or 5HT3 antagonists
Children with active infection
Children with congestive heart failure or known history of QT prolongation on electrocardiogram
Abnormal blood parameter (absolute neutrophil count < 1000/mm3, platelet count < 100 000/mm3)
Abnormal kidney function indicated by a serum creatinine more than the upper limit of normal (ULN) for age
Abnormal liver function test indicated by serum aspartate aminotransferase and alanine aminotransferase five times the ULN for age and serum bilirubin 1.5 times the ULN for age
Not willing to participate in the study or who have participated in any other clinical study in past 1 month. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients who achieved a complete response (defined as no vomiting, no use of rescue medication) during the 25–120 hours (delayed phase).
|
1. no vomiting, no use of rescue medication) during the 25–120 hours (delayed phase) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients who achieved complete response during the acute (0–24 hours) and overall phases.
2. Any adverse effect seen or reported by patient/caretaker. |
1. 0 - 24 hrs
2. 6 days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is An Investigator Initiated, Open Label, Prospective Study to evaluate effectiveness and safety of Fosaprepitant in Prevention of Chemotherapy Induced Vomiting in Pediatric Patients: FOSAPED Trial. Eligible subjects who meet all the inclusion and exclusion criteria will be recruited after obtaining informed written consent from the parents. Oral assent will be obtained for children between the age of 7 and 12 years. Patients randomized to the Fosaprepitant arm will receive Fosaprepitant 3 mg/kg (maximum 150 mg) as a short IV infusion in 100 ml normal saline over 30 minutes and Patients randomized to the placebo arm will receive 100 ml normal saline as a placebo over 30 minutes.Overall study duration for each subject is 6 days. From the start of chemotherapy infusion on day 1 through the morning of day 6 (0–120 h), each patient/caretaker will complete a diary. The diary will be checked daily by the investigator for patients admitted in the hospital, and entries by the parent/guardian will be confirmed telephonically by the investigator daily for patients discharged from the hospital. Diary will be collected back from the patient on Day 6. Complete response is defined as no vomiting and no need for rescue medication |