Evaluation of the effects of the cardioprotective diet on prevention of the incidence of cardiotoxicity in patients with breast cancer receiving Anthracycline
Our goal is to investigate the effects of a heart-protecting diet on anthracycline-induced heart poisoning.
Design
a parallel-group randomized clinical trial, One-way blind
Settings and conduct
60 patients with breast cancer who are candidates for chemotherapy with anthracyclines +/- trastuzumab are referred to the Iranian medicine specialist at week 0 to receive a diet, which will be explained as a 1 hour workshop, and will also adjust and receive diet based on weight and calories. A visit at week 8 and answering questions is recommended. The study is single-blinded, so that diet forms and recommendations are placed in the same folders and given to patients, and patients do not know which group has received the cardioprotective diet.
Participants/Inclusion and exclusion criteria
Women age 18-65; Breast cancer (based on pathology response); Candidate for chemotherapy including anthracyclines +/- trastuzumab؛
Exclusion criteria: History of heart disorders; Change the chemotherapy regimen for any reason; Unwillingness to continue the study; Follow less than 70% of trained dietary recommendations; History of liver disease
Intervention groups
First of patients enrolled and have completed consent form, medical history is taken. All patients are screened for weight, height, blood pressure, and demographic information, and recorded tests.
Both groups receive chemotherapy with anthracyclines +/- trastuzumab (Herceptin) and other routine recommendations and care. In addition to the above, the intervention group receives a heart-protective diet will receive
Main outcome variables
left ventricular ejection fraction; LV global longitudinal strain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131218015860N7
Registration date:2021-11-16, 1400/08/25
Registration timing:registered_while_recruiting
Last update:2021-11-16, 1400/08/25
Update count:0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Ghazaleh Heydarirad
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 6027
Email address
dr.ghazalrad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of the cardioprotective diet on prevention of the incidence of cardiotoxicity in patients with breast cancer receiving Anthracycline
Public title
Evaluation of the effects of the cardioprotective diet on prevention of the incidence of cardiotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women age 18-65
Breast cancer (based on pathology response)
Candidate for chemotherapy including anthracyclines +/- trastuzumab
25 ≤BMI ≤ 19
Willingness to participate in the study
Exclusion criteria:
History of heart failure
History of coronary artery disease
Symptoms of heart failure (functional shortness of breath, orthopedics, PND)
Ejection Fraction less than or equal to 40
Use of beta-blockers or ACEI
Change the chemotherapy regimen for any reason
Unwillingness to continue the study
Follow less than 70% of trained dietary recommendations
History of liver disease (except grade 1 and 2 fatty liver)
History of kidney disease (other than history of urinary stones)
• History of depression (taking antidepressants)
BMI greater than 25 and less than 19
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is first done by random sequence generation. A simple randomization method will be used to generate a random sequence. The method of simple randomization in this study is the use of a random number table. A random number table is a set of numbers that are generated without a specific pattern or order and in a completely random form and has become a table. In order to use the table of random numbers, we first preset the table to read the numbers (from left to right). Then the numbers are considered for the study groups so that even numbers will be considered for the experimental group and odd numbers will be considered for the control group. The second step is the concealment of the randomization allocation because the assigned group will not be specified before the individual is assigned. In this study, due to the fact that sampling is multicenter, the central randomization method will be used to hide the allocation. In this method, the random sequence is given to a person in the school of Traditional Medicine and sampling is performed in three centers. Based on the order in which the participants entered the study, the researcher contacted the mentioned person in the School of Traditional Medicine and asked about the random assignment of the participant to the experimental or control group. Communication methods include the use of telephone, SMS, fax, e-mail, and so on.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness in this study is single blind. This means that patients receive similar packages and they do not know that the intervention group is receiving an extra sheet containing heart-protective dietary recommendations.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.258
Health conditions studied
1
Description of health condition studied
cardiotoxicity in patients with breast cancer receiving Anthracycline
ICD-10 code
C00-C97
ICD-10 code description
Malignant Neoplasms
Primary outcomes
1
Description
left ventricular ejection fraction
Timepoint
In weeks 0, 8 and 18 from the beginning of the intervention
Method of measurement
Echocardiography
2
Description
LV global longitudinal Strain (GLS)
Timepoint
In weeks 0, 8 and 18 from the beginning of the intervention
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Alteration of the cardiac marker troponin
Timepoint
Weeks 0, 8 and 18 from the beginning of the intervention
Method of measurement
blood test (Measurement of cardiac troponin enzyme). This enzyme is measured by the enzyme immunoassay method according to standard conditions with ELISA device and with a series of calibrated pipettes.
2
Description
Quality of Life
Timepoint
Weeks 0, 8 and 18 from the beginning of the intervention
Method of measurement
Quality of Life Questionnaire (EORTC - QOL Br23)
Intervention groups
1
Description
Intervention group: The recipient of the diet protects the heart. First, a history is taken of the patients who have entered the study and completed the consent form. All patients are evaluated for weight, height, blood pressure, and demographic information, and patient tests are recorded. Both groups will receive chemotherapy with anthracyclines +/- trastuzumab (Herceptin) and other recommendations and the usual care, in addition to the above, the experimental group will receive a diet rich in heart tonics. This diet is similar to the diet recommended by Mozaffarian, which uses foods that are recommended as heart protectors. Since there is no standard guideline or standard protocol to prevent cardiovascular complications, in this study, the recommended diet for the participants of the experimental group is based on the Mozaffarian proposed diet. Dr. Mozaffarian et al. - are nutritionists who have focused on cardiovascular health for many years and have conducted numerous epidemiological studies on nutrition and the prevention of cardiovascular disease - they suggest a nutrient-based diet as a healthy diet for the heart.
Category
Prevention
2
Description
Control group: Patients who have entered the plan and completed the consent form will have a history. All patients are evaluated for weight, height, blood pressure, and demographic information and tests are recorded. Both groups of chemotherapy with anthracyclines +/- trastuzumab (Herceptin) and other recommendations and care Receive the usual, the control group will not receive CpD.