Evaluation of the effects of quince (Cydonia Oblonga Mill.) fruit syrup on reduction of cardiotoxicity induced by Trastuzumab (Herceptin) in patients with breast cancer
Determining the Effects of Blue Fruit Extract to (Cydonia Oblonga Mill) on Reducing Heart Complications from Prescribing Trastuzomab (Herceptin) in Patients with Breast Cancer
Design
Samples will be selected from breast cancer patients who have been diagnosed with the disease for the first time. After reviewing the criteria for entering and exiting the study and explaining and obtaining informed consent, patients will be randomly assigned to one of the two groups receiving fruit blueberry extract to (A) or placebo (B).
Settings and conduct
This study will be a two-course clinical trial. The study population will be randomly selected from HER2-positive breast cancer patients referred to the clinic and hospital affiliated to Zanjan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Criteria for entering the study include: willingness to participate in the study, breast cancer in the early stages of the disease, HER2 positive, women over 18 years and the absence of underlying heart problems and criteria for leaving the study include: other cancers, thyroid disorders or Kidney, receiving other vitamin or mineral supplements, patients with a body mass index of less than 18.5 and also a reluctance to continue participating in the project for any reason.
Intervention groups
After reviewing the criteria for entering and exiting the study and explaining and obtaining informed consent, patients will be randomly assigned to one of the two groups receiving fruit blueberry extract to (A) or placebo (B).
Main outcome variables
Patients will start taking fruit syrup at the same time as receiving the first dose of herceptin and will receive the syrup daily for three months. All patients will be examined at the beginning and end of three months for cardiac factors, including echocardiographic results (left ventricular esophagus) and ECG.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200427047219N1
Registration date:2020-05-10, 1399/02/21
Registration timing:prospective
Last update:2020-05-10, 1399/02/21
Update count:0
Registration date
2020-05-10, 1399/02/21
Registrant information
Name
Mohammad Reza Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 3635
Email address
eskandarimr@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of quince (Cydonia Oblonga Mill.) fruit syrup on reduction of cardiotoxicity induced by Trastuzumab (Herceptin) in patients with breast cancer
Public title
Effects of quince fruit syrup on reduction of cardiotoxicity induced by Herceptin in patients with breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer in the early stages of the disease
HER2 positive
Women over 18 years
Lack of underlying heart problems
The desire to participate in the study
Exclusion criteria:
Suffering from other cancers
Thyroid disorders
Kidney disorders
Getting other vitamin or mineral supplements
Patients with lower body mass index18/5
Lack of desire to continue participating in the project
Age
From 38 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple accidental
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers will be unaware of the contents of the bottles during the study and whether participants will receive the extract or placebo. Containers containing placebo and extract are coded by a third party and delivered to patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences, Ethics Committee
Street address
زنجان، بلوار آزادی، ستاد مرکزی دانشگاه علوم پزشکی زنجان، ساختمان دوم، طبقه سوم، معاونت تحقیقات و فناوری
City
ZANJAN
Province
Zanjan
Postal code
4515613191
Approval date
2020-01-16, 1398/10/26
Ethics committee reference number
IR.ZUMS.REC.1393.413
Health conditions studied
1
Description of health condition studied
Patients with breast cancer who are taking herceptin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
1. Determining the effect of quince syrup on cardiac function-related factors (left ventricular emptying fraction) in patients with breast cancer receiving fruit syrup by comparison with patients with breast cancer receiving placebo. 2- Determining the effect of quince syrup on the findings of ECG in patients with breast cancer receiving the syrup compared to patients receiving placebo.3. Determining the effect of quince syrup on the plasma levels of troponin I in patients with breast cancer receiving fruit syrup who have evidence of cardiomyopathy by comparing them with patients with breast cancer receiving placebo who have evidence of cardiomyopathy.4. Determining the effect of quince syrup on creatinine plasma plasma levels in patients with breast cancer receiving fruit syrup by comparing with patients with breast cancer receiving placebo
Timepoint
Patients will drink the syrup daily with some water for three months. The placebo will appear in the same bottles as the intervention group. The syrup bottles and placebo are given to patients on a monthly basis, and the researcher will follow up on the consumption or report possible side effects on the phone and on a weekly basis.
Method of measurement
Blood sampling to check the blood levels of biomarkers related to cardiac poisoning caused by prescribing herceptin in this disease will be done at the beginning and end of the study, ie 3 months later.
Secondary outcomes
1
Description
1- Receiving fruit syrup has an effect on heart function factors (left ventricular emptying fraction) in patients with breast cancer. 2- Receiving fruit syrup has an effect on the findings of ECG in patients with breast cancer. Fruit syrup affects the amount of troponin I in patients with breast cancer who have had cardiomyopathy. 4. Fruit syrup intake affects the amount of creatine kinase in patients with breast cancer.
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the start of the syrup
Method of measurement
Ventricular drainage fraction by echocardiography and troponin I by immunoenzymatic fluorescent assay
Intervention groups
1
Description
Intervention group: Patients with breast cancer who take herceptin and take syrup with it
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Mohammad Reza
Street address
Valiasr Medical Center, above Valiasr Square, Sheikh Fazlollah Nouri Highway
City
Zanjan
Province
Zanjan
Postal code
77978-45157
Phone
+98 24 3377 0801
Fax
+98 24 3377 0751
Email
valiasr@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Deputy Minister of Research and Technology
Street address
Deputy of Research and Technology, Third Floor, Second Building, Central Headquarters of Zanjan University of Medical Sciences, Azadi Boulevard
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6130
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Pharmacology and Toxicology, School of Pharmacy, Zanjan University of Medical Sciences, 45139-56184 Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45139-56184
Phone
+98 24 3347 3638
Email
eskandarimr@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Eskandari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of Pharmacology and Toxicology, School of Pharmacy, Zanjan University of Medical Sciences, Zanjan, Iran, Postal Code: 45139-56184
City
Zanjan
Province
Zanjan
Postal code
45139-56184
Phone
+98 24 3347 3635
Fax
+98 24 3347 3639
Email
eskandarimr@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Eskandari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of Pharmacology and Toxicology, School of Pharmacy, Zanjan University of Medical Sciences, Zanjan, Iran, Postal Code: 45139-56184
City
Zanjan
Province
Zanjan
Postal code
45139-56184
Phone
+98 24 3347 3635
Fax
+98 24 3347 3639
Email
eskandarimr@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available