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
|
|
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
|
|
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. |