Evaluation of the effect of carvedilol in the prevention of cardiovascular complications induced by (5fu (5Fluorouracil) therapy in gastrointestinal cancer (GI) patients
We aim to evaluate the efficacy of carvedilol on preventing 5fu (5 ّfluorouracil) induced cardiovascular complications in patients with gastrointestinal cancer
Design
In this randomized triple-blind study Clinical trial with control group, phase 3 on 60 patients, block randomization method was used for randomization.
Settings and conduct
This study will be performed on 60 patients between 18 and 80 years old with gastrointestinal, in Imam Khomeini Hospital in Ardabil. Patients would be selected to participate in the study according to the inclusion and exclusion criteria. Patients' identification; stage of cancer, ECG, troponin level, and primary echocardiographic findings would be registered in the questionnaire. The patient's ECG, troponin level, and echocardiography would be checked before and after all 3 courses of chemotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-All patients with gastrointestinal cancer who are in the age range of 18 to 80 years and are treated with 5fu
2- LVEF > 50%
Exclusion criteria:
1. Patients with a history of (PCI, CABG, and Plavix use).
2-valve stenosis and cardiomyopathy
3. Ischemic signs in ECG
4. At any stage of the study suffer from acute myocardial ischemia.
Intervention groups
First group will receive carvedilol 6.25 twice a day and second group will receive placebo twice a day from two weeks prior to chemotherapy till one week after chemotherapy.
Main outcome variables
The main outcome of the study is cardiotoxicity occurrence during or after chemotherapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200907048646N1
Registration date:2020-10-03, 1399/07/12
Registration timing:registered_while_recruiting
Last update:2020-10-03, 1399/07/12
Update count:0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
reza fereydoonzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0326
Email address
r.fereydounzadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-20, 1399/06/30
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of carvedilol in the prevention of cardiovascular complications induced by (5fu (5Fluorouracil) therapy in gastrointestinal cancer (GI) patients
Public title
Evaluation of the effect of carvedilol in patients with gastrointestinal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All gastrointestinal cancer patients in the age range of 18 to 80 years old underwent 5FU therapy.
LVEF (left ventricular Ejection Fraction)>50%
Exclusion criteria:
Patients with IHD (history of PCI, CABG, and Plavix consumption )
Mitral stenosis and cardiomyopathy
ECG changes characteristic to ischemia (ST-elevation more than 0.5mm and ST-depression more than 1 mm)
Acute myocardial ischemia at any stage of the study (ECG changes characteristic to ischemia, increased cardiac enzymes, or ischemic manifestations on echocardiography).
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a triple-blinded study. In fact, both Carvedilol and Placebo have been placed in a box of the same color and size by the pharmacist. The physician and Analyser do not know about the content of the boxes which have A, B on them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil Uiversity of medical sience