| CTRI Number |
CTRI/2024/05/068139 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This is a study to compare two types of medicines (four drugs vs extended four drugs) for the prevention of nausea and vomiting in chemotherapy for bone marrow transplant patients |
|
Scientific Title of Study
|
Standard vs extended four-drugs for chemotherapy-induced nausea and vomiting prophylaxis in hematopoietic stem cell transplant (SENVIT): A phase III randomized control 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 |
Debabrata Mohapatra |
| Designation |
Felllow |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 701, BMT ward, 7th floor, Department of Medical oncology, Dr BRAIRCH, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9818964089 |
| Fax |
|
| Email |
debabrata.shreedev.mohapatra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepam Pushpam |
| Designation |
Associate proffessor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
2nd Floor, Department of Medical oncology, Dr BRAIRCH
South
DELHI
110029
India |
| Phone |
9650629370 |
| Fax |
|
| Email |
deepampushpam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepam Pushpam |
| Designation |
Associate proffessor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
2nd Floor, Department of Medical oncology, Dr BRAIRCH
South
DELHI
110029
India |
| Phone |
9650629370 |
| Fax |
|
| Email |
deepampushpam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, INDIA, PIN- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Ansari Nagar, Delhi, INDIA
PIN: 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Deepam Pushpam |
All India Institute of Medical Sciences, New Delhi |
BMT ward, Room 702-709. Department of Medical Oncology.
Dr BRA IRCH
South
DELHI |
9650629370
deepampushpam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, (2) ICD-10 Condition: D60-D64||Aplastic and other anemias and other bone marrow failure syndromes, (3) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extended 4 drugs |
Cap Aprepitant 125 mg on day 1, 80mg daily till 6 days from the beginning of conditioning regimen or till last day of conditioning regimen whichever is longer.
Dexamethasone 12 mg IV OD on day 1 followed by 8mg IV OD on days 2 and 3
Ondansetron 8 mg IV TDS from day 1 till 6 days after the last day of conditioning
Tab. Olanzapine 5 mg PO OD from day 1 till 6 days after the last day of conditioning
|
| Comparator Agent |
Standard 4 drugs |
Cap Aprepitant 125 mg on day 1, 80mg on days 2 and 3
Dexamethasone 12 mg IV OD on day 1 followed by 8mg IV OD on days 2 and 3
Ondansetron 8 mg IV TDS from day 1 till last day of conditioning
Tab. Olanzapine 5 mg PO OD from day 1 till last day of conditioning
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 12yrs- 65 yrs. undergoing:
a. Conditioning for autologous hematopoietic stem cell transplant
b. Conditioning for allogenic hematopoietic stem cell transplant
2. Weight ≥ 30 kg
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1A) Complete Response
Complete response (CR) was defined as absence of vomiting/ retching and no more than mild nausea during the specified phase.
1B) Vomiting counts
Number of vomiting episodes separated by at least 5 minutes of nausea and retching free interval |
From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2) Overall CR rates will be further subdivided into that for acute and delayed phase:
2A) Acute: Any episode occurring after the administration of the first chemotherapy dose until 24 h after the last chemotherapy in the conditioning regimen.
2B) Delayed: Any episode occurring from 24 h up to 6 days after the last dose of chemotherapy in the conditioning regimen.
|
From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen. |
3) Complete Protection
No nausea, no vomiting and no use of rescue medications for either nausea or vomiting.
|
From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen. |
| 4) Counts of rescue antiemetic doses defined as any therapy given in addition to the standard treatment, for uncontrolled retching/ vomiting, based on clinical judgement |
From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen. |
| Individual toxicity episodes |
From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen. |
| 6) Comparison of quality of life scores between the two arms |
From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen. |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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)
|
14/06/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This trial is to compare two prophylactic antiemetic regimens in the setting of hematopoietic stem cell transplant (HSCT)
Purpose: To compare the chemotherapy induced nausea and vomiting rates between standard 4 drugs vs extended 4 drugs in patients undergoing HSCT
Hypothesis: Extended 4 drugs improves the chemotherapy induced nausea and vomiting rate by at least 20% as compared to standard 4 drugs. |