| CTRI Number |
CTRI/2024/03/063697 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ondansetron and Dexamethasone Comparative Efficacy trial |
|
Scientific Title of Study
|
A Phase III Randomized open label Non Inferiority study to Evaluate the efficacy of Oral Ondansetron and Dexamethasone vs Intravenous Ondansetron and Dexamethasone in prevention of chemotherapy induced nausea and vomiting in patients receiving highly emetogenic chemotherapy HEC |
| Trial Acronym |
ONDEXCEL trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurmeet Kaur |
| Designation |
Senior Resident |
| Affiliation |
All Institute of medical sciences New Delhi |
| Address |
IRCH AIIMS Sri Aurobindo Marg
Ansari Nagar East
New Delhi
DELHI
110029
India |
| Phone |
09643709700 |
| Fax |
|
| Email |
gurmeetkaur56857@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepam Pushpam |
| Designation |
Assisstant Professor |
| Affiliation |
All india institute of medical sciences, New Delhi |
| Address |
IRCH AIIMS Sri Aurobindo Marg
Ansari Nagar East
Central
DELHI
110029
India |
| Phone |
9650629370 |
| Fax |
|
| Email |
deepampushpam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepam Pushpam |
| Designation |
Assisstant Professor |
| Affiliation |
All india institute of medical sciences, New Delhi |
| Address |
IRCH AIIMS Sri Aurobindo Marg
Ansari Nagar East
Central
DELHI
110029
India |
| Phone |
9650629370 |
| Fax |
|
| Email |
deepampushpam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
IRCH All India Institute of Medical Sciences, New Delhi |
| 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 Gurmeet Kaur |
IRCH AIIMS New Delhi |
Medical Oncology OPD and Ward of IRCH AIIMS and NCI Jhajjar AIIMS
Department of Medical Oncology
IRCH AIIMS
Sri Aurobindo Marg
Ansari Nagar East 110029
Central
DELHI |
9643709700
gurmeetkaur56857@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research AIIMS, Ansari Nagar NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Ondansetron and Dexamethasone |
Inj Ondansetron 8 mg or 0.15mg per kg IV 30 minutes prior to chemotherapy and then if required for vomiting on day 2 to day 4
Inj Dexamethasone 12mg or 3mg per m2 IV 30 minutes prior chemotherapy followed by Tab Dexamethasone 8mg per oral once a day for 3 days
Tab Aprepitant 125mg Per Oral OD D1 80mg OD on D2 and D3 at least 1 hour before chemotherapy
Tab Olanzapine 5mg or 0.14mg per kg per oral 30 minutes before chemotherapy then 5mg OD on day 2 to day 4
|
| Intervention |
Oral Ondansetron and Dexamethasone |
Tab Ondansetron 8 mg or 0.15mg/kg Per Oral 1 hour before chemotherapy and then if required for CINV on day 2 to day 4
Tab Dexamethasone 12mg or 3mg per m2 Per Oral OD 1 hour before chemotherapy followed by 8mg once a day for 3 days
Tab Aprepitant 125mg Per Oral OD on D1 then 80mg OD on D2 and D3
Tab Olanzapine 5mg or 0.14mg per kg Per Oral 30 minutes before chemotherapy then 5mg OD on day 2 to day 4
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female subjects aged 18 years and above
ECOG PS 0 to 2
Treatment naïve newly diagnosed cancer patients
Patients who will be receiving single day regimens of HEC containing AC anthracyclines and
cyclophosphamide Cisplatin Dacarbazine and Actinomycin D
Patient who are willing to sign a written informed consent and participate in the study
|
|
| ExclusionCriteria |
| Details |
Vomiting retching or more than mild nausea within 24 hours before the start of chemotherapy
Active infection or uncontrolled medical condition other than malignancy
Severe cognitive compromise history of central nervous system disease eg cerebral hemorrhage cerebral infarction brain metastases or a seizure disorder
Patients having serum creatinine 2mg per dl or more
Patients with gastric surgery and small intestinal surgery or gastrointestinal obstruction
Patients on Ryles tube or Patients who are unable to swallow
Patients scheduled for or receiving radiotherapy
Patients having an aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range and total bilirubin concentration of 2 mg per dL or more
Patients with cardiac arrhythmia uncontrolled congestive heart failure or acute myocardial infarction within the previous 6 months
Patients with history of uncontrolled diabetes mellitus
Patients receiving medication that strongly induces CYP3A4 activity eg rifampicin phenytoin carbamazepine phenobarbital
Patients with history of using any of the following drugs within 48 h before enrollment opioids aprepitant 5-HT3-RA dexamethasone dopamine receptor antagonists antihistamines benzodiazepines or phenothiazine antipsychotic agents
Patients receiving Drugs other than chemotherapeutic agents with the potential to cause emesis
Hypersensitivity to study drug: Known prior severe hypersensitivity to investigational product or any component in its formulations
Pregnant patient or those with positive pregnancy test done using pregnancy test kit within 7 days before enrolment |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients who achieve complete response in chemotherapy induced nausea and vomiting during the overall phase means 0 to 120 hours of receiving Highly emetogenic chemotherapy |
0 to 120 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 The proportion of patients who achieve a complete response in CINV during the acute phase 0 to 24 hours
2 The proportion of patients who achieve a complete response in CINV during the delayed phase 25 to 120 hours
3 The proportion of patients with breakthrough vomiting episodes during acute delayed and overall phases and need of rescue antiemetics
4 The proportion of patients with no nausea during acute delayed and overall phases
5 Proportion of patients achieving complete protection no vomiting no use of rescue medications and no nausea of CINV
6 Ascertain the side effects in each arm
7 Evaluate the cost effectiveness cost benefit and cost utility analysis of both the study arms for all enrolled patients
|
0 t0 24 hours
25 to 120 hours |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
15/03/2024 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Although guidelines recommend the use of both oral as well as intravenous antiemetics no head to head trials are available to compare efficacy of oral vs intravenous ondansetron and dexamethasone combination for prevention of CINV in treatment naïve newly diagnosed cancer patients As oral ondansetron and dexamethasone have ease of administration in comparison to IV and are cost effective with possibility of less side effects This study intends to generate level 1 evidence for supporting the use of oral ondansetron and dexamethasone in lieu of IV We will be comparing oral ondansetron and dexamethasone with its Intravenous formulation for prevention of CINV in newly diagnosed cancer patients recieving single day highly emetogenic chemotherapy. |