Since high-dosage chemotherapy and stem cell transplantation have become important in the treatment of many malignancies, and these regimens are often associated with symptoms of nausea and vomiting, Appropriate and effective control of this complication is an important step in improving the nutritional quality of these patients. With conventional anti emetic treatments patients who receive high-dose chemotherapy suffer from particular delayed nausea and vomiting which emphasis on necessity of new anti-emetic methods. In this study a group of 40 patients and a matched control group (40 patients)who undergo stem cell transplantation in Taleghani bone marrow transplantation center will be included. Patients in control group will receive conventional anti emetic therapy ( dexamethasone 8 mg IV daily and Grarisetron1.5 mg bid IV up to third day post chemotherapy) and the same therapy with Aprepitant 120 mg PO first day and 80 mg po on the second and third days of chemotherapy) in study group. The rate of early and late nausea, vomiting, possible side effects and complications will be evaluated .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107026930N1
Registration date:2012-08-14, 1391/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-14, 1391/05/24
Registrant information
Name
Mahshid Mehdizadeh
Name of organization / entity
Shahid Beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1372
Email address
mehdizadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anti-emetic efficacy of Aprepitant in patients undergo hematopoitic stem cell transplantation
Public title
Evaluation of anti-emetic efficacy of Aprepitant in patients undergo hematopoitic stem cell transplantation in a teaching hospital
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who undergo autologus bone marrow transplantation. Exclusion criteria: severe hepatic and renal failure during drug administration; hypersensitivity to the drug.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical Sciences Research Center
Street address
No 10, Shams alley, Vali-e-asr ave
City
Tehran
Postal code
Approval date
2011-05-15, 1390/02/25
Ethics committee reference number
100
Health conditions studied
1
Description of health condition studied
Autologous bone marrow transplantation
ICD-10 code
Z94.8
ICD-10 code description
Other transplanted organ and tissue status
2
Description of health condition studied
emesis
ICD-10 code
K92.0
ICD-10 code description
Haematemesis
Primary outcomes
1
Description
The patient's nutritional status
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
2
Description
The need for tpn
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Recorded in the file
3
Description
Number of vomiting
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient - the nurse reported
4
Description
Nausea
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
Secondary outcomes
1
Description
Constipation
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
2
Description
The number of cases disposed
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
3
Description
Headache
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
4
Description
Diarrhea
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
5
Description
fever
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
By Digital Thermometers
6
Description
hiccup
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
7
Description
Anorexia
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
8
Description
Seizure
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Ask the patient
9
Description
Mucositis
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Examination
10
Description
Alkaline phosphatase levels
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
11
Description
Amylase levels
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
12
Description
The rate of bilirubin
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
13
Description
Transaminase levels
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
14
Description
Blood glucose
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
15
Description
Creatinine levels
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
16
Description
The amount of calcium
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
17
Description
Magnesium levels
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Laboratory measurement
18
Description
Occurrence SoS
Timepoint
5 days prior to the intervention until after patient discharge
Method of measurement
Examination
Intervention groups
1
Description
Intervention group: dexamethasone 8 mg IV daily Grarisetron1.5 mg bid IV Aprepitnt slow infusion (120 mg first day - the second and third days of 80 mg ( po)
Category
Treatment - Drugs
2
Description
Control Group: Granisetron 1.5 mg bid IV
dexamethasone 8 mg IV daily,
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
BMT unit of Taleghani hospital
Full name of responsible person
Dr. Mahshid Mehdizadeh
Street address
Taleghani hospital, next to Shahid Beheshti university of medical scinces, Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyyed Amir Mohammad Mortazavian
Street address
Shahid Beheshti University of Medical Sciences, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti university of medical scinces
Full name of responsible person
Dr. Mahshid Mehdizadeh
Position
preceptor
Other areas of specialty/work
Street address
Taleghani BMT center, Taleghani hospital, Evin
City
Tehran
Postal code
1985717413
Phone
+98 21 2303 1499
Fax
Email
mahshid_mehdizadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahshid Mehdizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Taleghani BMT center, Taleghani hospital, next to Shahid Beheshti university of medical scinces, Evin
City
Tehran
Postal code
1985717413
Phone
+98 21 2303 1499
Fax
Email
mahshid_mehdizadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Ghadirifard
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8814 2028
Fax
Email
arghadirifard@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)