| 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
|
|
|
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
|
|
|
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
|
|
|
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. |