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
Objectives: 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. (2) (Design) study population: women with BC treated with tamoxifen; groups: Intervention and placebo groups; 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. (3) Setting and conduct: 20 breast cancer patients will be randomly allocated into either intervention or placebo group. (4) 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. (5) 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. (6) main outcome measures: Measurement of serum levels of VEGF-A and ANG-2 at baseline and the endpoint of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082111335N6
Registration date:2015-12-27, 1394/10/06
Registration timing:registered_while_recruiting
Last update:
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
2015-11-09, 1394/08/18
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
The inclusion criteria: The range of body mass index (BMI) is 20 to 35 kg/m2; Age: 30 – 65 years old; histopathologic confirmed breast malignancy; histopathologic grades of 2 and 3; tendency to participate in study; completed questionnaire; tamoxifen consumption.
The 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 and/or vomiting, headache and vertigo.
Age
From 30 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Third floor, Central Building 2, Tabriz University of Medical Sciences.
City
Tabriz
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of 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
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
Vice Chancellor for Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Saeed Pirouzpanah
Position
Nutrition, Ph.D.
Other areas of specialty/work
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Attar Neyshabori St, Golgasht St
City
Tabriz
Postal code
51665118
Phone
+98 41 3335 7580
Fax
+98 41 1334 0634
Email
pirouzpanahs@tbzmed.ac.ir, pirouzpanah@gmail.com
Web page address
WWW.TBZMED.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Saeed Pirouzpanah
Position
Nutrition, Ph.D.
Other areas of specialty/work
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar neyshabori Ave., Golgash Ave.
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
+98 41 3334 0634
Email
Pirouzpanahs@tbzmed.ac.ir, pirouzpanah@gmail.com
Web page address
WWW.TBZMED.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Zahra Shahveghar-Asl
Position
Nutrition, M.Sc. Candidate
Other areas of specialty/work
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar neyshabori Ave., Golgasht Ave.
City
Tabriz
Postal code
Phone
+41 33801688
Fax
+98 41 3334 0634
Email
shahveghar.z@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)