Study the preventive effect of Carvedilol therapy against Adriamycin-induced acute cardiotoxicity in breast cancer patients by measurement of myocardial deformation index
Main Outcome: This study is aimed to investigate the protective effect of carvedilol on cardiac changes during chemotherapy with Adrimycin by using strain, strain rate echocardiography
Design and setting: 70 breast cancer patients, who were being under chemotherapy with Adriamycin, were enrolled. Patients were randomly divided into two groups. In case group every patient was given 12.5 mg Carvedilol daily from 7 days before chemotherapy to 7 days after finishing the chemotherapy course. In control group patients were given placebo exactly same as Carvedilol in case group. 6 cycles of chemotherapy at 3-week intervals were performed. Strain and strain rate echocardiography were done before starting, 10 days after 3rd cycle and 10 days after 6th cycle of chemotherapy.
Participants including major eligibility criteria: Breast cancer patients who are under chemotherapy with Adriamycin in Qaem center, Mashhad are enrolled. These patients have neither documented heart disease nor contraindication for beta blocker, and their cancer is not metastatic.
Interventions: Carvedilol tab 12.5 mg daily
Variables: Strain, strain rate indices in echocardiography
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013093012924N1
Registration date:2014-09-02, 1393/06/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-02, 1393/06/11
Registrant information
Name
Ahmad Tashakori Beheshti
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 517 7368
Email address
tashakoriba851@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the preventive effect of Carvedilol therapy against Adriamycin-induced acute cardiotoxicity in breast cancer patients by measurement of myocardial deformation index
Public title
Study the preventive effect of Carvedilol therapy against Adriamycin-induced acute cardiotoxicity in breast cancer patients by measurement of myocardial deformation index
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
breast cancer patients who are candidate for chemotherapy with adriamycin.
Exclusion criteria:
documented heart disease; history of radiation or chemotherapy for cancer; metastatic disease; atrial fibrillation; BMI more than 30; creatinin more than 2; EF less than 30%; pulmonary congestion; beta blocker contraindications; insulin dependent diabetes mellitus; major depression; suicide attempt; pregnancy
Age
To 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical sciences, ethics committee
Street address
Daneshghah Avenue, Ghoreishi building
City
Mashhad
Postal code
Approval date
2011-12-31, 1390/10/10
Ethics committee reference number
۸۹۱۹۷
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
2
Description of health condition studied
heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure
Primary outcomes
1
Description
strain rate
Timepoint
before intervention, at the middle of intervention, after intervention
Method of measurement
echocardiography
Secondary outcomes
1
Description
complications of carvedilol
Timepoint
during intervention
Method of measurement
by taking history
Intervention groups
1
Description
Carvedilol tab 12.5 mg daily for 5 months during chemotherapy
Category
Treatment - Drugs
2
Description
placebo tab daily for 5 months during chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem educational, reseaarch and treatment center
Full name of responsible person
Street address
Ghaem hospital, Dr. shariati Square, beginning of Ahmadabad Avenue, Mashhad-Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Ghoreishi building, Daneshgah avenue
City
Mashhad
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, Mashhad 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
cardiovascular research center, mashhad university of medical sceinces
Full name of responsible person
Ahmad Tashakori Beheshti
Position
MD
Other areas of specialty/work
Street address
Ghaem hospital-Dr. shariati Square, beginning of Ahmadabad Avenue
City
Mashhad
Postal code
Phone
+98 51 1840 0001
Fax
Email
atb6628@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
cardiovascular research center, mashhad university of medical sciences
Full name of responsible person
Ahmad Tashakori Beheshti
Position
MD
Other areas of specialty/work
Street address
Ghaem hospital-Dr Shariati Square, beginning of Ahmadabad Avenue
City
Mashhad
Postal code
Phone
+98 51 1840 0001
Fax
Email
atb6628@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cardiovascular research centre, Mashhad University of Medical Sciences
Full name of responsible person
Malihe Bokaiyan
Position
MD
Other areas of specialty/work
Street address
Ghaem hospital-Dr Shariati Square, beginning of Ahmadabad Avenue
City
Mashhad
Postal code
Phone
00
Fax
Email
bakaiyanm851@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)