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CTRI Number  CTRI/2020/01/023076 [Registered on: 31/01/2020] Trial Registered Prospectively
Last Modified On: 17/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study on comparison of addition of Olanzapine 5 mg versus Olanzapine 10 mg as anti-emetic to standard anti-emetic regime for Doxorubicin and Cyclophosphamide in breast cancer 
Scientific Title of Study   An open label randomized trial of comparison of addition of Olanzapine 5 mg versus Olanzapine 10 mg as anti-emetic to standard anti-emetic regime for Doxorubicin and Cyclophosphamide in breast cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thinley Dorji 
Designation  Junior Resident 
Affiliation  Armed Forces Medical College 
Address  Department of Internal Medicine Armed Forces Medical College Solapur Road Pune 411040

Pune
MAHARASHTRA
411040
India 
Phone  09155785155  
Fax    
Email  dorji.thinleydr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Thinley Dorji 
Designation  Junior Resident 
Affiliation  Armed Forces Medical College 
Address  Department of Internal Medicine Armed Forces Medical College Solapur Road Pune 411040

Pune
MAHARASHTRA
411040
India 
Phone  09155785155  
Fax    
Email  dorji.thinleydr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Thinley Dorji 
Designation  Junior Resident 
Affiliation  Armed Forces Medical College 
Address  Department of Internal Medicine Armed Forces Medical College Solapur Road Pune 411040

Pune
MAHARASHTRA
411040
India 
Phone  09155785155  
Fax    
Email  dorji.thinleydr@gmail.com  
 
Source of Monetary or Material Support  
Malignant Disease Treatment Centre, Command Hospital (Southern Command), Pune 
 
Primary Sponsor  
Name  No Funding Available 
Address  No funding available 
Type of Sponsor  Other [No funding available] 
 
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 TVSVGK TILAK  Medical Oncology OPD  Malignant Disease Treatment Centre, Command Hospital, Southern Command Pune 411040
Pune
MAHARASHTRA 		 9845187315
9845187315
drtilaktvs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Armed Forces Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tab Olanzapine 10 mg OD x 4 days  All subjects will receive the following standard regime of triple antiemetics during chemotherapy (5,11): Aprepitant 125 mg D1, 80 mg D2-D3 Ondansetron 8 mg D1 Dexamethasone 8 mg D1, 4 mg BD D2-D3 The intervention arms will receive Olanzapine 5 mg and Olanzapine 10 mg to be taken orally after dinner from Days 1 to 4. The drugs will be generic tablets manufactured by state-approved quality-assured companies within India. There are no specific recommendations regarding antiemetic therapy after the completion of protocol treatment, so prophylactic use of olanzapine is permissible. 
Comparator Agent  Tab Olanzapine 5 mg OD x 4 days  All subjects will receive the following standard regime of triple antiemetics during chemotherapy (5,11): Aprepitant 125 mg D1, 80 mg D2-D3 Ondansetron 8 mg D1 Dexamethasone 8 mg D1, 4 mg BD D2-D3 The intervention arms will receive Olanzapine 5 mg and Olanzapine 10 mg to be taken orally after dinner from Days 1 to 4. The drugs will be generic tablets manufactured by state-approved quality-assured companies within India. There are no specific recommendations regarding antiemetic therapy after the completion of protocol treatment, so prophylactic use of olanzapine is permissible. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  This study will include patients receiving doxorubicin and cyclophosphamide regimen in the adjuvant setting and those who were on olanzapine as one of the antiemetic prophylaxis:
Adults aged 18 years and above;
Chemotherapy-naive breast cancer of any stage;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (19);
Written informed consent;
Able to understand and describe patient-reported outcomes.
Subjects who were on medications such as antibiotics and motility enhancers such as metoclopramide shall be included after a washout period of 7 days. 
 
ExclusionCriteria 
Details  This study will exclude the following subjects:
Scheduled to receive abdominal or pelvic radiotherapy within 8 days of Day 1 of the study;
Acute surgical conditions such as gastrointestinal obstruction, appendicitis, and pancreatitis;
History of hypersensitivity or allergy to any of the study drugs or similar compounds;
Symptomatic brain metastasis, or gastrointestinal tumours;
Liver and renal function derangements;
Left ventricular ejection fraction <50%;
Documented Parkinson’s disease;
Patients on antipsychotic drugs such as chlorpromazine, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone;
Patients on antiepileptic drugs;
Pregnant or breastfeeding women and women of childbearing potential, as well as men wishing to father children;
Habitual smoking;
History of using any of the following drugs within 48 h before enrolment: opioids, aprepitant, 5-HT3-RA, dexamethasone, dopamine receptor antagonists, antihistamines, benzodiazepines or phenothiazine antipsychotic agents. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is complete response (proportion of patients do not report nausea and vomiting) within 120 hours (05 days) after initiation of chemotherapy.   The primary outcome is complete response (proportion of patients do not report nausea and vomiting) within 120 hours (05 days) after initiation of chemotherapy.  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes are complete response rates in the acute phase (0 – 24 h), delayed phase (24 – 120 h) and the overall phase (0 – 120 h); time to treatment failure; and selected adverse reactions due to the regimen.  The secondary outcomes are complete response rates in the acute phase (0 – 24 h), delayed phase (24 – 120 h) and the overall phase (0 – 120 h); time to treatment failure; and selected adverse reactions due to the regimen. 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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)   03/02/2020 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction: Chemotherapy induced nausea and vomiting are the commonest side effects. While standard triple antiemetics are prescribed for breast cancer (aprepitant, ondansetron and dexamethasone), Olanzapine, an antipsychotic, has been found to reduce chemotherapy induced nausea and vomiting by 25-50%. This response has been reported in more than 85-90% of patients receiving chemotherapy in breast cancer. However, very little is known if Olanzapine 5 mg is as effective as Olanzapine 10 mg, and if dose is related to common side effects – somnolence and fatigue.

 

Objectives: This study intends to assess the safety and efficacy of oral Olanzapine 5 mg versus Olanzapine 10 mg as antiemetic in the prevention and treatment of nausea and vomiting when added to standard regime for Doxorubicin and Cyclophosphamide chemotherapy in breast cancer.

 

Methods: This is an open label randomized clinical trial conducted among patients with breast cancer receiving chemotherapy with Doxorubicin and Cyclophosphamide at a malignant disease treatment centre in Western Maharashtra, India. Olanzapine 5 mg or 10 mg PO will be added for four days to standard antiemetic therapy. Eligible patients will be randomized through random sequence generation into two equivalence arm with a 1:1 allocation. With expected success rate of at 87.9% in each arm and equivalence limit of 20 and allowance for attrition of 10 per arm, the sample size is 59 per arm, total of 118 subjects. Informed written consent will be taken to extract patient and chemotherapy related details from patient records. Primary outcome of nausea and vomiting will be assessed using the Rhodes Index and the MASCC Antiemetic Tool through serial interviews. Data will be entered into EpiData 3.1 and descriptive statistics used to describe the outcomes.

 

Results: The proportion of complete response (absence of) of nausea and vomiting will be described. If not complete response, the time to nausea and vomiting will be described in Kaplan-Meir curve.

 

Conclusion: Efficacy of Olanzapine 5 mg vs 10 mg in producing complete response to prevention and treatment of chemotherapy induced nausea and vomiting. Proportion of somnolence and fatigue in the two arms.

 

Trail registration: CTRI (process initiated).

 
 
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