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CTRI Number  CTRI/2017/12/010869 [Registered on: 13/12/2017] Trial Registered Retrospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Aprepitant and Olanzapine in the treatment of vomiting 
Scientific Title of Study   A comparative study of Aprepitant and Olanzapine in the prevention of chemotherapy induced nausea and vomiting in carcinoma of breast patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh S 
Designation  Assistant professor 
Affiliation  Mysore medical college and research institute 
Address  Department of Radiotherapy, Room no 22 KR hospital, Irwin road

Mysore
KARNATAKA
570001
India 
Phone  9886873788  
Fax    
Email  dal_muk1@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh S 
Designation  Assistant professor 
Affiliation  Mysore medical college and research institute 
Address  Department of Radiotherapy, Room no 22 KR hospital, Irwin road


KARNATAKA
570001
India 
Phone  9886873788  
Fax    
Email  dal_muk1@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akshya 
Designation  Senior Resident 
Affiliation  Mysore medical college and research institute 
Address  Department of Pharmacology Mysore medical college Irwin road Mysore
Department of Radiotherapy, Room no 22 KR hospital, Irwin road
Mysore
KARNATAKA
570001
India 
Phone  9739097923  
Fax    
Email  j.k_akshay@yahoo.com  
 
Source of Monetary or Material Support  
Mysore medical college and research institute Department of Radiotherapy Room no 22 KR hospital Mysore 570001 Karnataka, India 
 
Primary Sponsor  
Name  Mysore medical college ad research institute 
Address  Department of Radiotherapy, Room no 22 KR hospital, Irwin road 
Type of Sponsor  Government medical college 
 
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 Mukesh S  Mysore medical collehe and research institute  Department of Radiotherapy, Room no 22 KR hospital, Irwin road
Mysore
KARNATAKA 
9886873788

dal_muk1@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Breast cancer ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tablet Aprepitant 125mg per orally on day 1 and Tablet Aprepitant 80mg on day 2 and day 3  This drug is given from the day of chemotherapy up to day 3 in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 
Intervention  Tablet Olanzapine 10mg per orally day 1 to 3  This drug is given from the day of chemotherapy up to day 3 in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Female 
Details  1. Histologically confirmed breast cancer.
2. Chemotherapy naive patients.
3. Not complaining of nausea in the past 24
hours prior to initiation of chemotherapy.
4. Renal and liver function tests of the
patients within the normal range
5. Patients with child bearing potential had to
have a negative urine pregnancy test

 
 
ExclusionCriteria 
Details  1. History of seizure disorder
2. Brain Metastasis
3. Treatment with another antipsychotic agent
such as risperidone, quetiapine, clozapine,
phenothiazine or butyrophenone for 30 days
prior to or during protocol therapy.
4. Hypersensitivity to olanzapine
5. History of cardiac arrhythmia
6. Uncontrolled congestive cardiac failure or
acute myocardial infarction in the previous
6 months
7. History of diabetes mellitus
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Compare the efficacy of Aprepitant and Olanzapine in the prevention of Chemotherapy Induced Nausea.  Day 1 to day 5 from the start of chemotherapy 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare the efficacy of Aprepitant and Olanzapine in the prevention of acute and delayed emesis   Day 1 to day 5 from the start of chemotherapy 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/12/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1.Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J. Delayed nausea and vomiting continue to reduce patients quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472-78 2.Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008;358(23):2482-94 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Chemotherapy Induced Nausea and Vomiting (CINV) the most common side effect of chemotherapy is associated with a significant deterioration in quality of life  and is perceived by patients as a major adverse effect of treatment.

Chemotherapy is a common modality for treatment of Carcinoma Breast. Regardless of the fact that chemotherapy improves survival, it has its own toxicity and side effects of which nausea and vomiting being significant can affect patient compliance. To avoid the clinical sequelae of CINV like dehydration, electrolyte imbalance, malnutrition, anorexia, stress and anxiety, it is imperative to provide prophylaxis and treatment for CINV. 

The principal neurotransmitters that drive CINV in all forms are serotonin, dopamine, acetylcholine, and substance P.  The use of 5-hydroxytryptamine3 (5-HT3) receptor antagonist plus dexamethasone has significantly improved the control of acute CINV.  Recent studies have demonstrated additional improvement in the control of acute CINV and delayed CINV with the use of newer agents: Palonosetron, a second generation 5-HT3 receptor antagonist.  Aprepitant, the first agent available in the drug class of neurokinin-1 (NK1)-receptor antagonists and Olanzapine, an antipsychotic which is used in the treatment of psychotic symptom, blocks multiple neurotransmitters in the central nervous system.  These newer drugs incorporated in prophylactic regimens for CINV have resulted in significantly reduced rates of this feared complication of cytotoxic chemotherapy. A recent randomized trial evidence has suggested that Olanzapine may have a role in both the prevention and treatment of CINV. 

 
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