Protocol summary

Study aim
To evaluate efficacy of adding Aprepitant to doublet dexamethasone/Ondansetron for prevention of moderately emetogenic chemotherapy regimens' emesis
Design
placebo-controlled double blind, randomised clinical trial of efficacy
Settings and conduct
160 cancer patients under moderate emetogenic chemotherapy regimen, in Imam Hussein Hospital between December 2018 and march 2019 were enrolled. Patients were treated with triple antiemetic therapy comprising oral administration of 125 mg Aprepitant and intravenous injection of 12 mg Dexamethasone, and 8mg Ondansetron on day 1, followed by 80 mg Aprepitant on days 2 and 3. The control group received the same regimen without Aprepitant.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: aged between 18 - 70 years, Karnofsky index of 50% or more; Women at reproductive ages should had received an appropriate contraceptive ; Exclusion Criteria: causes of nausea or vomiting unrelated to the chemotherapy; uremia or electrolyte disturbance; active infection; uncontrolled seizure; candidate for radiation therapy of brain or upper abdomen in less than a week; received an anti emetic 24 h before ;lab studies : wbc<3000/mm3 , anc<1500/mm3 , plt<100000 mm3, ALT & AST>2.5 * upper limit of normal, Bill & Cr > 1.5* upper limit of normal ; opium addicted; poor compliance ; received corticosteroids for more than 3 months and more than 50 mg prednisone daily; Carlson’s comorbidity scale of 3 or more.
Intervention groups
Patients were treated with triple antiemetic therapy comprising oral administration of 125 mg Apprepitant ,intravenous injection of 12 mg dexamethasone, and 8mg ondansetron on day 1, followed by 80 mg Abitant on days 2 and 3. The control group received the same regimen without Aprepitant
Main outcome variables
nausea and vomiting; complete response ( no vomiting, no need of rescue medication)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191103045317N1
Registration date: 2019-11-30, 1398/09/09
Registration timing: retrospective

Last update: 2019-11-30, 1398/09/09
Update count: 0
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
Mania Rajabzadeh kheradmardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 3634
Email address
mania_008@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-12-21, 1397/09/30
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison between the effect of Triplet Aprepitant/Dexamethasone/Ondansetron vs. doublet Dexamethasone/Ondansetron for prevention of moderately emetogenic chemotherapy: placebo-controlled double blind, randomised clinical trial of efficacy
Public title
efficacy of adding Aprepitant into antiemesis prophylactic regimen in nausea and vomiting of moderate emetogenic regimen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer patients receiving moderate emetogenic chemotherapy regimens,formed the study cohort. Eligible patients were adults (aged between 18 - 70 years) with a karnofsky index of 50% or more). Women at reproductive ages should had undertaken an appropriate contraceptive method
Exclusion criteria:
causes of nausea or vomiting unrelated to the chemotherapy (e.g., gastrointestinal obstruction, massive ascites, widespread brain metastases, history of motion sickness or vestibular dysfunction, uremia or electrolyte disturbance) active infection uncontrolled seizure candidate for radiation therapy of brain or upper abdomen in less than a week an emetic episode 24 h before initiation of chemotherapy complications that prohibited Dexamethasone use one of the followings observed in their lab studies : wbc<3000/mm3 , anc<1500/m m3 , plt<100000 mm3, ALT & AST>2.5 * upper limit of normal,Bill & Cr > 1.5* upper limit of normal opium addicted poor compliance receiving corticosteroids for more than 3 months and more than 50 mg Prednisone daily; Carlson’s comorbidity scale of 3 or more Any drugs with antiemetic efficacy other than the study drugs wouldn’t been allowed before the study started, and were recorded on.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization sequences was created using Stata10 statistical software ; using random block sizes of 4. participants stratified by a center of 1:1 allocation ,randomly assigned to either the case (Aprepitant ) or the control (placebo ) group; with equal proportion of male and female patients in each group to eliminate the confounding effect of sex.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and medical treatment team were unaware of being in case or control groups, as the drugs were coded by the pharmaceutical company, and they were decoded after the time the data were collected and analyzed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Jorjani center of radiotherapy-oncology, Imam Hussein Hospital, Madani Ave., Imam Ali Blvd,.Nezan Abad Town,
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2017-08-22, 1396/05/31
Ethics committee reference number
67m

Health conditions studied

1

Description of health condition studied
nausea and vomiting
ICD-10 code
R11.2
ICD-10 code description
Nausea with vomiting, unspecified

2

Description of health condition studied
adverse reaction
ICD-10 code
T45
ICD-10 code description
Poisoning by, adverse effect of and underdosing of primarily systemic and hematological agents, not elsewhere classified

Primary outcomes

1

Description
Proportion of patients experiencing nausea and vomiting with MSKCC questionnaire
Timepoint
day 1 and 5 of chemotherapy
Method of measurement
MSKCC nausea and vomiting questionnaire

Secondary outcomes

1

Description
complete response
Timepoint
day 1 and day 5 of chemotherapy
Method of measurement
MSKCC nausea and vomiting questionnaire

2

Description
complete control
Timepoint
day 1 and day 5 of chemotherapy
Method of measurement
MSKCC nausea and vomiting questionnaire

3

Description
overall response
Timepoint
day 1 and day 5 of chemotherapy
Method of measurement
MSKCC nausea and vomiting questionnaire

4

Description
resistance to treatment
Timepoint
day 1 and day 5 of chemotherapy
Method of measurement
MASCC nausea and vomiting questionnaire

Intervention groups

1

Description
Intervention group: Patients were treated with triple antiemetic therapy comprising oral administration of 125 mg Aprepitant and intravenous injection of 12 mg Dexamethasone, and 8mg Ondansetron on day 1, followed by 80 mg Aprepitant on days 2 and 3
Category
Prevention

2

Description
Control group: received intravenous injection of 12 mg Dexamethasone, and 8mg Ondansetron on day 1, and placebo
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein hospital
Full name of responsible person
Mania Rajabzadeh Kheradmardu
Street address
Shahid madani Ave., Nezam Abad Town
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Email
mania_008@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Rezghi
Street address
Jorjani Center of Radiation-Oncology, Imam Hussein Hospital, Shahid madani Ave., Nezam Abad Town,
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Abidi Pharmaceutical iran
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mania Rajabzadeh Kheradmardi
Position
resident of radiation oncology
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Jorjani center of radiation oncology, Imam Husein Hospital, Shahid Madani Ave., Nezam Abad Town
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
00982÷77543634
Email
mania_008@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Morteza Tabatabaeefar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Hussein Hospital, Shahid madani Ave., Nezam Abad Town
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Email
tabatabaeefar@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Yaghoubi jouybari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Hussein Hospital, Shahid Madani Ave., Nezam Abad Town
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7754 3634
Email
dryaghobi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Patients' ID, sex, case or control, nausea, vomiting, complete control, complete response , overall response, resistance to treatment,
When the data will become available and for how long
3 months after results publication
To whom data/document is available
researchers of academic and scientific centers
Under which criteria data/document could be used
researching utilization of similar studies
From where data/document is obtainable
contributing author: mania_008@yahoo.com
What processes are involved for a request to access data/document
An applying email from the named accepted centers
Comments
Loading...