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CTRI Number  CTRI/2025/08/092535 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   EFFECT OF OLANZAPINE AND ONDANSETRON ON VOMITING 
Scientific Title of Study   Effect of Olanzapine and Ondansetron for Prevention of Platinum based Chemotherapy-Induced Nausea and Vomiting: An Open Label, Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karthik G 
Designation  Postgraduate 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  6366329804  
Fax    
Email  dr.karthik7175@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bhuvana K  
Designation  Professor 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  9900383738  
Fax    
Email  drbhuvanak2010@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhuvana K  
Designation  Professor 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  9900383738  
Fax    
Email  drbhuvanak2010@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  G.Karthik 
Address  Postgraduate, Department of Pharmacology, Sri Devaraj Urs Medical college, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India. Pin code -563101  
Type of Sponsor  Other [self] 
 
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 
DR G KARTHIK  RL Jalappa Hospital and Research Centre   Department of Medical Oncology, 2nd Floor , Tamaka ,Kolar, Karnataka
Kolar
KARNATAKA 
6366329804

dr.karthik7175@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee, Sri Devaraj Urs Academy of Higher Research and Education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R112||Nausea with vomiting, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Olanzapine 5mg   After chemotherapy, both groups (Olanzapine and control) will receive an intravenous injection of dexamethasone 12mg and ondansetron 8mg once on day 1. From day 2 to day 5, all patients will receive dexamethasone tablets 4mg three times a day and ondansetron tablets 8mg once daily, both administered orally. Additionally, patients in the Olanzapine group will receive olanzapine tablets 5mg orally at bedtime from day 1 to day 4. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 75 years of either gender
Patients receiving Platinum based chemotherapy regimen for cancer treatment
Eastern Co-operative Oncology Group (ECOG) performance status - 0/1
No prior/ current use of anti-psychotic medications
No history of hypersensitivity to olanzapine or study drugs  
 
ExclusionCriteria 
Details  Patients experiencing clinically significant nausea in 24 hours preceding the first dose
Pregnant or lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of olanzapine and ondansetron in prevention and control of Platinum based chemotherapy
induced nausea and vomiting  
Nausea and vomiting is assessed by Multinational Association of Supportive Care in Cancer Tool (MASCC) and Visual Analogue Scale (VAS) score at baseline, chemotherapy cycle 1,2,3,4,5,6  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the adverse effects of olanzapine & ondansetron using WHO causality assessment scale & Naranjo scale.  Adverse effects of drug & safety will be assessed by WHO causality assessment scale & Naranjo scale at baseline, chemotherapy cycle 1,2,3,4,5,6  
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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 4 
Date of First Enrollment (India)   01/09/2025 
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 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  

Platinum-based chemotherapy is a cornerstone in the treatment of various malignancies but is often complicated by chemotherapy-induced nausea and vomiting (CINV). CINV can severely affect patients’ adherence to cancer therapy and diminish their quality of life, especially as conventional antiemetic regimens may not completely prevent these distressing symptoms. Both acute (within 24 hours) and delayed (after 24 hours) phases of nausea and vomiting present significant management challenges, particularly in patients receiving highly emetogenic agents like cisplatin.

Olanzapine, primarily an atypical antipsychotic, has gained attention for its potent antiemetic effects due to its blockade of multiple neurotransmitter receptors involved in nausea pathways—including dopaminergic, serotonergic, adrenergic, and histaminic receptors. Its broad pharmacological profile makes it a candidate for both acute and delayed CINV, either alone or as an adjunct to standard therapy. The drug’s use at a lower dose (5mg) is being actively explored, aiming to maximize benefit while minimizing risk of sedation and other side effects.

This open-label, randomized controlled trial conducted at R.L. Jalappa Hospital and Research Centre enrolled 116 adult patients undergoing platinum-based chemotherapy. Participants were randomized to two groups: one received olanzapine in addition to standard antiemetics (dexamethasone and ondansetron), while the control group continued with standard antiemetics alone. Efficacy was measured using validated questionnaires to assess the presence and severity of nausea and vomiting in both the acute and delayed phases across 3–6 chemotherapy cycles. Adverse effects of the study drugs were systematically tracked using established causality and probability scales.

 
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