Cardioprotective effect of quercetin supplement in against of cardiac induced toxicity of doxorubicin in breast cancer patients: a randomized, double-blined, placebo-controlled trial.
this study is to investigate the effect of Quercetin cardiac protection as an oral supplement in breast cancer patients undergoing chemotherapy with Doxorubicin.
Design
Randomized clinical trial (phase II), with parallel intervention (30 subjects) and placebo groups (30 subjects), double-blind.
Settings and conduct
The study is double blind (all patients and researchers) .Treatment with oral supplementation Quercetin is started 1 week before the onset of chemotherapy at a dose of 250 mg daily to the end of the chemotherapy (3 months) period. All patients are under treatment protocol (60 mg / m2) with Doxorubicin + cyclophosphamide (2600 mg / m 2) every 3 weeks for 4 periods. To evaluate cardiac effects and cumulative dose of the drug, echocardiography is performed for all patients at first and 24 hours prior to the start of chemotherapy as well as the end of the chemotherapy (end of 3 months) and 6 months and one year after the end of the treatment period. The study is carried out at Razi hospital laboratory.
Participants/Inclusion and exclusion criteria
Eligible patients include women aged 21-69 years with sinus rhythm and normal ventricular drainage fraction, normal liver and kidney function, and normal hematology.
Intervention groups
Eligible patients are randomly divided into two groups of intervention and placebo with equal ratios. Patients in the intervention group take quercetin oral supplement. Quercetin oral supplementation is continued 2 weeks prior to the onset of chemotherapy at a dose of 250 mg (once a day) from the beginning and end of the chemotherapy (3 months) period, and the patients in the control group receive placebo two weeks before the end of the course.
Main outcome variables
Cardiac toxicity of doxorubicin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042892N1
Registration date:2019-03-11, 1397/12/20
Registration timing:retrospective
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Mona Haddad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
haddad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-16, 1397/02/26
Expected recruitment end date
2019-03-05, 1397/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cardioprotective effect of quercetin supplement in against of cardiac induced toxicity of doxorubicin in breast cancer patients: a randomized, double-blined, placebo-controlled trial.
Public title
The effect of co-administration of quercetin supplemented cardiac cardiovascular system with cardiotoxicity of doxorubicin in patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible patients include women aged 21-69 years with sinus rhythm and normal ventricular drainage fraction, normal liver and kidney function, and normal hematology.Previously don`t have any document for chemotherapy or radiotherapy for other types of malignancies. They don`t have CHF. Have not experienced myocardial infarction. Do not suffer from obstruction or heart valves stenosis. They don`t have specific disease or specific drug therapy that affects cardiac function. EF do not have less than 55%.They don`t have cardiovascular disease risk factors , such as hypertension, high fat, and do not include smokers. Women in this clinical trial study are not pregnant and don`t have systolic pressure of less than 90 mmHg.
Exclusion criteria:
Unwillingness to appear in the plan, to make any changes to the treatment or use of the drug. At any time from the implementation of the plan, in the event of any unwanted side effects, the oral supplement will be discontinued and the patient will be excluded from the study.
Age
From 1360 years old to 1360 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Limited Randomization is done in which both groups have the same sample size and the random allocation rule is also used to balance the number of people assigned to each group. For this purpose, SAS software and websites www.graghpad.com/quickcalcs/index.cf are used. Moreover, the SNOSE method is used to hide the allocation, the use of non-transparent sealed packets with random sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this randomized clinical trial , placebo-controlled (Phase II), which is done in double blind (all patients and researchers are blinded to studying),of 100 women with breast cancer (C50-C50 disease code) ; Malignant neoplasm of breast). With the initial diagnosis and referral to the Behesht Clinic of Rasht in year 2018, which will be treated with anthracycline (doxorubicin) will be used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
41939-5558
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.GUMS.REC.1397.455
Health conditions studied
1
Description of health condition studied
Patients with Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
The cardiac toxicity of doxorubicin is a primary outcome.
Timepoint
The amount of troponin is measured one month after the start of chemotherapy and the end of the course.
Method of measurement
Troponin test
Secondary outcomes
1
Description
Quercetin cardiovascular effect is a secondary consequence.
Timepoint
Echocardiography will be done at the end of the chemotherapy (first 3 months), 6 months later and one year later
Method of measurement
Echocardiography
Intervention groups
1
Description
Intervention group: Patients in the intervention group receiving oral quercetin supplementation. Oral supplementation Quercetin (pure America manufacturer) continues 2 weeks before starting a chemotherapy dose of 250 mg (once a day) from the beginning and end of the chemotherapy (3 months) period.
Category
Treatment - Drugs
2
Description
Control group: the patients in the control group who received two They will receive a placebo week before the end of the course. Oral supplements of quercetine and placebo are similar in appearance, color and odor.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Diseases Research Center Guilan University of Medical Sciences
Full name of responsible person
Mona Hadad Zahmatkesh
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3361 8177
Email
Gums.icrc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Vice-chancellor research and technology of the Guilan University
Street address
Rasht, Namjoo Ave., Shahid Siadati St., Faced to the 17th Shahrivar Hospital, Old Building, School of Health, University of Technology Research and Technology
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 6394
Email
reaserch@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mona Hadad Zahmatkesh
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3361 8177
Email
haddad@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mona Hadad Zahmatkesh
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3361 8177
Email
haddad@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mona Hadad Zahmatkesh
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3361 8177
Email
Heshmat@gums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available