Investigation of the Effect of Curcumin on Preventing Anthracycline-Induced Cardiomyopathy in Patients with Breast Cancer - A Randomized Clinical Trial Study
Evaluation of prophylactic effect of curcumin in prevention of anthracycline induced cardiotoxicity in breast cancer chemotherapy
Design
This study is a randomized, double-blind, placebo-controlled study. a total of 40 patients will be randomly allocated in two groups of intervention and placebo.
Settings and conduct
Forty consecutive breast cancer patients admitted to the Reza oncology and planned antracycline-based chemotheraphy, if provide written informed consent will be enrolled in the study. Patients meeting inclusion/exclusion criteria will be randomized in 1:1 ratio to receive curcumin or placebo. Trial will be commenced 7 days before starting chemotherapy and continued for 6 months and at the end, the incidence of cardiotoxicity is evaluated and compared in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who affected with breast cancer
Exclusion criteria: the presence of cardiomyopathy; coronary heart disease; mitral valve disease; prior chemotherapy or radiotherapy; alcohol abuse;
any contraindications to curcomin; Patients who take other cardiac medications such as angiotensin-converting enzyme inhibitors,
angiotensin receptor blockers, non-dihydropyridine calcium channel blockers, diuretics, statins or beta-blockers .
Intervention groups
Intervention group: 20 patients in whom the Curcumin is given orally at a dose of 500 mg/day for 6 months.
Control group: 20 patients in whom placebo is given for 6 months.
Main outcome variables
Echocardiographic evaluation includes measuring the LV end-diastolic (LVEDD) and end-systolic dimensions (LVESD), systolic and diastolic function, discharge fraction and longitudinal global strain for all patients at baseline, and endpoint of chemotherapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190224042818N1
Registration date:2019-02-27, 1397/12/08
Registration timing:prospective
Last update:2019-02-27, 1397/12/08
Update count:0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
Hassan Mehrad-Majd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2694
Email address
mehradmajdh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of Curcumin on Preventing Anthracycline-Induced Cardiomyopathy in Patients with Breast Cancer - A Randomized Clinical Trial Study
Public title
Investigation of the Effect of Curcumin in preventing complications of chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast cancer who planned for antracycline-based chemotherapy
Exclusion criteria:
presence of cardiomyopathy (dilated, restrictive or hypertro-phic) detected by baseline echocardiography
Past medical history of coronary heart disease
Moderate or severe aortic and/or mitral valve disease
Prior chemotherapy or radiotherapy,
Alcohol abuse
Any contraindications to Curcumin
Patients on other cardiac medications such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, non-dihydropyridine calcium channel blockers, diuretics, statins or beta-blockers
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random Allocation Software, random blocks with different volumes of 4 to 8 randomly spaced two color papers are concealed in envelopes and delivered to the secretary at Chemotherapy Dept. The secretary will draw the first upper color paper from the envelope for each patient. The medication or placebo, which will be blind for the secretary, is delivered to the patient according to the color of the paper. The patients initials along with the color of paper will be recorded in a list for further tracking.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, the secretary, the oncologist, and the echoman (cardiologist) will be blinded to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Faculty of Medicine, Azadi Square, Pardis campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2018-07-18, 1397/04/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.503
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
left ventricular (LV) end-systolic and end-diastolic diameters (LVESD, LVEDD), systolic and diastolic function
Timepoint
Echocardiographic measurements including LVESD, LVEDD at baseline. and at 6-month after the start of chemoterapy
Method of measurement
Echocardiography measurements by a specialist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nano-Comintern at a dose of 80 mg/day (Exir Nano Sina Co., Iran) is given orally form for 7 consecutive days before chemotherapy until 6 months later.
Category
Prevention
2
Description
Control group: placebo is commenced 7 days before starting chemotherapy and will be continued for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Fatemeh Homaei Shandiz
Street address
Kohsangi Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3801 2694
Email
omidhos@mums.ac.ir
2
Recruitment center
Name of recruitment center
Reza Radiotherapy & Oncology Center
Full name of responsible person
Mahdiyeh Dayani
Street address
Shahrak Gharb, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
9184166759
Phone
+98 51 3801 2694
Email
Info@rroc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University, No. 19, Daneshgah St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Mehrad-Majd
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Ghaem Hospital, AhmadAbad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2694
Email
mehradmajdh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Mehrad-Majd
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Ahmad-Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2694
Fax
Email
mehradmajdh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Mehrad-Majd
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Ahmad-Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2694
Fax
Email
mehradmajdh@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
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