The effect of cholecalciferol supplementation on serum levels of vascular endothelial growth factor-A and angiopoietin-2 in breast cancer patients co-administered with tamoxifen: a randomized controlled clinical trial
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General information
2018-03-16, 1396/12/25
2018-05-17, 1397/02/27
2018-0305-1617 00:00:00
Protocol summary
Study aim
The effect of cholecalciferol supplementation on serum levels of vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (ANG-2) in breast cancer (BC) patients treated with tamoxifen
Design
study population: women with BC treated with tamoxifen; sample size: 20 participants in each group; blinding: Triple blind; Participants, distributor of supplement and laboratory assessor will be blinded from the assignment in interventional groups; randomization: Blocked random allocation; single or multi central: Multi-central study involved oncology clinics, Hematology and Oncology Research Center (HORC) and Nour-Nejat hospital; study phase: 2.
Settings and conduct
Intervention: intervention group will consume a 50000 IU vitamin D capsule per week and placebo group will consume a soft-gel capsule that contain liquid paraffin per week similar in appearance (color, size and odor) for the duration of 8 weeks intervention.
Participants/Inclusion and exclusion criteria
The main inclusion criteria: Confirmed breast malignancy upon histopathologic reports ; Range of BMI 20 to 35 kg/m2; Age: 30 – 65 years; histopathologic grade of 2 and 3; co-administered with tamoxifen. The main exclusion criteria: being at clinical stage 4; pregnancy; lactation; acute renal or liver failure; using antiepileptic medications and contraceptive drugs; history of hormonal related diseases (such as diabetes, hyperthyroidism and poly cystic ovary syndrome); having nausea, vomiting, headache and vertigo.
Intervention groups
Intervention and placebo groups
Main outcome variables
Measurement of serum levels of VEGF-A and ANG-2 at baseline and the endpoint of intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2015082111335N6
Registration date:2015-12-27, 1394/10/06
Registration timing:prospective
Last update:2018-11-12, 1397/08/21
Update count:2
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Saeed Pirouzpanah
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133575803
Email address
pirouzpanahs@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-01-25, 1394/11/05
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
2016-01-25, 1394/11/05
Actual recruitment end date
2018-03-16, 1396/12/25
Trial completion date
2018-05-17, 1397/02/27
Scientific title
The effect of cholecalciferol supplementation on serum levels of vascular endothelial growth factor-A and angiopoietin-2 in breast cancer patients co-administered with tamoxifen: a randomized controlled clinical trial
Public title
The effect of cholecalciferol supplementation on angiogenic factors in breast cancer survivors co-administered with tamoxifen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The range of body mass index (BMI) is 20 to 35 kg/m2
30 – 65 years old
histopathologic confirmed breast malignancy
histopathologic grades of 2 and 3
tendency to participate in study
completed questionnaire
tamoxifen consumption
Exclusion criteria:
Being at clinical stage 4
pregnancy
lactation
acute renal or liver failure
using antiepileptic medications and contraceptive drugs
history of hormonal related diseases (such as diabetes, hyperthyroidism and poly cystic ovary syndrome)
nausea
vomiting
headache
vertigo
Age
From 30 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Block random allocation was performed using a statistical software program
Blinding (investigator's opinion)
Triple blinded
Blinding description
Eligible patients were randomly assigned to the intervention and placebo groups. Packages containing cholecalciferol capsules were encoded in B and C to ensure that there is uninformed status for grouping in this study. Sampling in two groups of intervention and placebo was done by Random allocation software. Checking the eligibility of the participants and placing in the intervention and placebo groups was done by researcher who was unaware of the grouping and the type of supplements that they received during the study. The intervention group received 50000 IU cholecalciferol per week and the placebo group received capsules containing liquid paraffin that they were similar in appearance, size, color, and odor to cholecalciferol capsules. Patients, researcher and laboratory staff were unknown to the distribution of cholecalciferol and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabori St.,
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Approval date
2015-09-16, 1394/06/25
Ethics committee reference number
TBZMED.REC.1394.518
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
Serum levels of angiopoietin-2 and VEGF-A
Timepoint
Baseline and 8 week after baseline
Method of measurement
ELISA
Secondary outcomes
1
Description
Anthropometric parameters
Timepoint
Baseline and 8 week after baseline
Method of measurement
Waist circumference, body mass index (kg/m2), and waist to hip ratio
Intervention groups
1
Description
Intervention group: supplement therapy with a soft-gel of 50000 IU cholecalciferol(vitamin D) per week for 8 weeks the duration of intervention. The soft-gel produced by Zahravi pharmaceutical.
Category
Treatment - Drugs
2
Description
Placebo: Placebo soft-gel typically similar to vitamin D soft-gel in size, color and odor. BC patients will use a soft-gel that contain liquid paraffin every week for the duration of 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Clinics, Hematology and Oncology Research Center, Noor-Nejat hospital
Full name of responsible person
Zahra Shahveghar-Asl
Street address
Hafez st, Azadi Blvd, Noor-Nejat hospital
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Phone
+98 41 3335 7584
Email
shahveghar.z@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar Neyshabori Ave., Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Phone
+98 41 3337 7459
Fax
Email
rashidi@tbzmed.ac.ir
Grant name
Grant code / Reference number
TBZMED.REC.1394.518
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Saeed Pirouzpanah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Attar Neyshabori St, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Phone
+98 41 3335 7580
Fax
+98 41 1334 0634
Email
pirouzpanah@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeed Pirouzpanah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar neyshabori Ave., Golgash Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Phone
+98 41 3335 7580
Fax
+98 41 3334 0634
Email
pirouzpanah@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Shahveghar-Asl
Position
Nutrition, M.Sc. Candidate
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar neyshabori Ave., Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Phone
+41 33801688
Fax
+98 41 3334 0634
Email
shahveghar.z@gmail.com
Web page address
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
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Just a part of data can share.
When the data will become available and for how long
6 months after publication
To whom data/document is available
There is no limitation.
Under which criteria data/document could be used
There is no limitation.
From where data/document is obtainable
E-mail: pirouzpanah@gmail.com
What processes are involved for a request to access data/document
After sending a written request via e-mail, the files will be sent.