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CTRI Number  CTRI/2021/09/036663 [Registered on: 20/09/2021] Trial Registered Prospectively
Last Modified On: 11/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Steroid Free anti emetic combination 
Scientific Title of Study   Efficacy of olanzapine based, dexamethasone free anti emetic strategy in chemotherapy naive patients planned to receive oxaliplatin based moderately emetogenic chemotherapy: an open label single arm phase II trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akash Kumar 
Designation  Assistant Professor 
Affiliation  NCI 
Address  Room no1, 1st floor, academic block

Jhajjar
HARYANA
124105
India 
Phone  9910850134  
Fax    
Email  akashjha08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Akash Kumar 
Designation  Assistant Professor 
Affiliation  NCI 
Address  Room no1, 1st floor, academic block


HARYANA
124105
India 
Phone  9910850134  
Fax    
Email  akashjha08@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akash Kumar 
Designation  Assistant Professor 
Affiliation  NCI 
Address  Room no1, 1st floor, academic block


HARYANA
124105
India 
Phone  9910850134  
Fax    
Email  akashjha08@gmail.com  
 
Source of Monetary or Material Support  
NCI 
 
Primary Sponsor  
Name  NCI 
Address  Badsa, Jhajjar, Haryana 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vinod sharma  AIIMS  2nd Floor, Room No 229, Medical Oncology, BRA IRCH, AIIMS
Central
DELHI 		 9968969014

vinod_mbbs4u@yahoo.co.in 
Akash Kumar  NCI   Room no 1, 1st Floor, Academic Block, Medical Oncology, Badsa, Jhajjar
Jhajjar
HARYANA 		 9910850134

akashjha08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional ethics review  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 
Intervention  Olanzapine Arm  Tab or Injection Ondansteron 8mg on Day 1 Tab. Olanzapine 5mg once, day 1-3 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosis of malignancy
No prior chemotherapy and radiation therapy (RT)
Age of ≥ 18 – up to 65 years
ECOG Performance status (0-2)
Complete hemogram (ANC ≥1000/m3, TLC ≥3000/m3, Platelets ≥ 1,00,000/m3), Creatinine (≤ 2 mg/dl), SGOT / SGPT (≤ 3 X ULN, Bilirubin <2.0 mg/dl)
First cycle of moderately emetogenic chemotherapy defined as
Oxaliplatin at dose ≥80mg/m2 with or without other agents
Willing to give written informed consent for the study participation 
 
ExclusionCriteria 
Details  Patient receiving concurrent psychiatric drugs (clozapine, risperidone, quetiapine, phenothiazine etc), CNS depressants (azelastine, bromopride, bromperidol, buprenorphine), anti-Parkinson drugs (dopamine agonist), benzodiazepines, cabergoline, anti-cholinergic (glycopyrrolate, ipratropium, levosulpiride, potassium chloride, potassium citrate etc), metoclopramide, pimozide, quinolone, amifostine
Hypersensitivity to any of the drugs used in the study {Olanzapine, 5-HT3 antagonist – Ondansetron}
On systemic steroids
History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis
Symptomatic Brain metastasis / Carcinomatous Meningitis
History of nausea and vomiting in 24 hours prior to first dose of chemotherapy
Use of anti-emetic drugs (5-HT3 Antagonist) in last 24 hours
Started on opioids in last 48 hours
Female who is pregnant, or breast-feeding his children
Patients with dementia related psychosis or psychiatric disorder
No concurrent abdominal radiotherapy 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapy  To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapy 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the rate of complete response ((no emesis, no use of rescue medications) during the acute period (0-24 hours), delayed period (24 – 120 hours)
To determine the rate of nausea control assessed by “Edmontonsymptomassessment scale” (ESAS) during the acute period (0-24 hours), delayed period (24 – 120 hours) and overall period (0-120 hours)
To determine the rate of complete control during the overall period (0-120 hours)
To determine the rate of total control during the overall period (0-120 hours)
Toxicity pattern and incidence
Time to treatment failure
Prognostic factors associated with CINV control 		 5-7 days 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   22/09/2021 
Date of Study Completion (India) 20/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

  1. The CINV control rate for MEC ranges from 60% - 85%. The CINV rate varied substantially between different chemotherapy regimens (carboplatin, oxaliplatin). High CINV control rate with oxaliplatin based chemotherapy with two drug anti-regimen. Olanzapine: Cheap, safe and highly effective drug and increases the rate of complete response during the overall period by 20-30%. All these factors favours to evaluate prospectively the efficacy and feasibility of olanzapine based dexamethasone free anti emetic regimen in patients receiving oxaliplatin based moderately emetogenic chemotherapy regimen.

 
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