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CTRI Number  CTRI/2014/12/005333 [Registered on: 30/12/2014] Trial Registered Prospectively
Last Modified On: 01/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparision between Aprepitant and Dexamethasone For Preventing Postoperative Nausea And Vomiting In Breast Cancer Patients 
Scientific Title of Study   Aprepitant Versus Dexamethasone For Preventing Postoperative Nausea And Vomiting In Breast Cancer Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SACHIDANAND JEE BHARATI 
Designation  ASSISTANT PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ROOM NO 139,FIRST FLOOR,DR BRAIRCH,AIIMS,NEW DELHI-110029

South West
DELHI
110029
India 
Phone  29575101  
Fax    
Email  SACHIDADR@YAHOO.CO.IN  
 
Details of Contact Person
Scientific Query
 
Name  SACHIDANAND JEE BHARATI 
Designation  ASSISTANT PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ROOM NO 139,FIRST FLOOR,DR BRAIRCH,AIIMS,NEW DELHI-110029

South West
DELHI
110029
India 
Phone  29575101  
Fax    
Email  SACHIDADR@YAHOO.CO.IN  
 
Details of Contact Person
Public Query
 
Name  SACHIDANAND JEE BHARATI 
Designation  ASSISTANT PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ROOM NO 139,FIRST FLOOR,DR BRAIRCH,AIIMS,NEW DELHI-110029

South West
DELHI
110029
India 
Phone  29575101  
Fax    
Email  SACHIDADR@YAHOO.CO.IN  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  AIIMS 
Address  AIIMS, ANSARI NAGAR, NEW DELHI-110029 
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachidanand Jee Bharati  DR BRA IRCH,All India Institute of Medical Sciences  DR BRA IRCH,ROOM NO. 139,FIRST FLOOR,All India Institute of Medical Sciences (AIIMS),Anasri Nagar,New Delhi
South West
DELHI 
011-29575101

sachidadr@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institue Ethics Committee,AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, Patients scheduled for elective surgery of age 18yrs with breast cancer, ASA grade 1-3,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aprepitant  Patients in group I will receive 80 mg oral Aprepitant 3 hours before induction of anesthesia 
Comparator Agent  Dexamethasone  Patients in group II will receive 8mg dexamethasone intravenously at the time of induction of anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Patients scheduled for elective surgery of age >18yrs with breast cancer, ASA grade 1-3 
 
ExclusionCriteria 
Details  patients who had a history of drug abuse, hypersensitivity reaction, nausea and received antiemetic before surgery within 24 hours, pregnancy, breastfeeding status 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy variable will be episodes of nausea and or vomiting in the early and late postoperative period in first 24 hours  The primary efficacy variable will be episodes of nausea and or vomiting in the early and late postoperative period in first 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
The incidence of any adverse reaction to treatment in the two experimental groups will be recorded  till discharge 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2015 
Date of Study Completion (India) 31/07/2018 
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
Modification(s)  
In stage of manuscript writing 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Postoperative nausea and vomiting (PONV) is a major cause of morbidity in surgical patients. Several factors including age, gender, type of surgery and anesthetic agents, intraoperative opioid use, and duration of anesthesia, have been implicated as the causes of PONV. Variety of new drugs and anesthetic techniques has been introduced in the recent past to reduce PONV; however, the incidence still remains significantly high, ranging between 25% and 30% even after multimodal antiemetic regimens.

Breast surgery is associated with high incidence of PONV, ranging between 15% and 84%. Oncologic breast surgical procedures have been reported to have increased incidence of PONV. Patients with no known risk factors carries 10% risk of PONV and it increases exponentially to 61% and 79%, respectively, when 3 or 4 risk factors exist (female gender, nonsmoker, history of motion sickness, postoperative opioid use and a history of PONV).

In the recent times, studies have demonstrated the relationship between substance P, the CNS and emesis center. A new class of non-peptide neurokinin1 receptor antagonists (NK1RAs), demonstrated to have activity against both peripheral and central emetic stimuli. Human trials have examined NK-1 antagonists in the prevention of PONV, showing a decreased incidence. Aprepitant may have antiemetic effects beyond 48 h after surgery with special impact on post-discharge nausea and vomiting. Aprepitant, a highly selective, brain-penetrant NK-1 RA with a long half-life and preclinical efficacy against opioid-induced emesis, has demonstrated efficacy against chemotherapy-induced nausea and vomiting when combined with other antiemetic, and is the first in its class to be approved for this indication. NK-1 RA have been studied for prevention of PONV in abdominal and gynecological surgery and found to be effective but no literature is available regarding its use in breast cancer patient.  Considering the fact that breast cancer patients are at high risk of PONV, we planned this study of Aprepitant versus Dexamethasone for Preventing Postoperative Nausea and Vomiting in Breast Cancer Patients undergoing surgery.

 
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