Evaluation of the effects of Cydonia Oblonga Mill. fruit syrup on reduction of Biochemical complications induced by Trastuzumab (Herceptin) in patients with breast cancer: A randomized double blind clinical trial study
Determining the Effects of quince Fruit Extract in Reducing Biochemical Complications from Prescribing Herceptin in Patients with Breast Cancer
Design
Participants are randomly assigned to two groups of syrups containing blueberry fruit extract and placebo.
Settings and conduct
The study population will be randomly selected from HER2-positive breast cancer patients referred to clinics and hospitals affiliated with Zanjan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Criteria for entering include: willingness to participate in the study, breast cancer in the early stages of the disease, positive HER2, women over 18 years, life expectancy of more than 3 months, the person is at least able to walk and do Be your own personal affairs. Exclusion include: other cancers, thyroid or kidney disorders, receiving other vitamin or mineral supplements, patients with a body mass index of less than 18.5 and no The desire to continue participating in the project is for any reason.
Intervention groups
The group receiving the syrup contains the blue fruit extract and the group receiving the placebo
Main outcome variables
At the beginning of the study, a general and clinical information questionnaire, a food frequency questionnaire, and a nutritional status questionnaire for patients will be completed. Measurement and body composition measurements will be performed at the beginning and end of the study for patients. Blood sampling for biochemical, antioxidant and blood levels of biomarkers related to cardiac poisoning caused by prescribing herceptin in this disease will be performed at the beginning and end of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200427047219N2
Registration date:2020-05-31, 1399/03/11
Registration timing:prospective
Last update:2020-05-31, 1399/03/11
Update count:0
Registration date
2020-05-31, 1399/03/11
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
2020-09-05, 1399/06/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Cydonia Oblonga Mill. fruit syrup on reduction of Biochemical complications induced by Trastuzumab (Herceptin) in patients with breast cancer: A randomized double blind clinical trial study
Public title
Evaluation of the effects of Cydonia Oblonga Mill. fruit syrup on reduction of Biochemical complications induced by Herceptin in patients with breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Breast cancer in the early stages of the disease
HER2 positive
Women over 18 years
Life expectancy more than 3 months (with a doctor's diagnosis)
A person should at least be able to walk and do their own thing (WHO performance status 0-2)
Exclusion criteria:
Suffering from other cancers
Thyroid or kidney disorders
Get other vitamin or mineral supplements
Patients with a body mass index less than 18.5
Lack of willingness to continue participating in the project for any reason
Age
From 18 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a two-course clinical trial. The study population will be randomly selected from patients with HER2-positive breast cancer who go to clinics and hospitals affiliated with Zanjan University of Medical Sciences. Diagnosis will be made by an oncologist using blood tests, ultrasound, and, if necessary, additional procedures.
Blinding (investigator's opinion)
Double blinded
Blinding description
The container containing the extract and placebo will be uniform in appearance, and patients, as well as researchers, will be blind to the content of the contents of the bottles during the study and whether participants will receive the extract or placebo. For the preparation of placebo syrup, the base of the main syrup is used without extract, and for the uniformity of the shape, taste and smell of both types and types of syrup, apple essential oil and food coloring are allowed in very low doses. These syrups are made of sugar and according to the usp. 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
Committee of Animal Experimentation of Zanjan University of Medical Sciences, Zanjan
Street address
Azadi Blvd., Central Headquarters of Zanjan University of Medical Sciences, Second Building, Third Floor, Deputy of Research and Technology
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.ZUMS.REC.1399.072
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Biochemical factors including: ALP,GGT,ALT, AST
Timepoint
At the beginning of the experiment and 3 months after the intervention
Method of measurement
Laboratory kits
Secondary outcomes
1
Description
Biochemical factors
Timepoint
Start of study (before the start of the intervention) and 3 months later
Method of measurement
Laboratory kits
Intervention groups
1
Description
Intervention group: Patients with breast cancer receiving quince syrup