Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention and placebo groups
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Main outcome variables
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Measurement of serum levels of VEGF-A and ANG-2 at baseline and the endpoint of intervention
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2015-12-27, 1394/10/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for Research, Tabriz University of Medical Sciences.
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Expected recruitment start date
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2016-01-25, 1394/11/05
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Expected recruitment end date
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2018-03-16, 1396/12/25
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Actual recruitment start date
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2016-01-25, 1394/11/05
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Actual recruitment end date
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2018-03-16, 1396/12/25
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Trial completion date
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2018-05-17, 1397/02/27
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Scientific title
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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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Public title
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The effect of cholecalciferol supplementation on angiogenic factors in breast cancer survivors co-administered with tamoxifen
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 65 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
40
Actual sample size reached:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block random allocation was performed using a statistical software program
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-09-16, 1394/06/25
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Ethics committee reference number
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TBZMED.REC.1394.518
Health conditions studied
1
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Description of health condition studied
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Breast cancer
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ICD-10 code
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C50
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ICD-10 code description
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Malignant neoplasm of breast
Primary outcomes
1
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Description
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Serum levels of angiopoietin-2 and VEGF-A
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Timepoint
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Baseline and 8 week after baseline
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Method of measurement
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ELISA
Secondary outcomes
1
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Description
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Anthropometric parameters
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Timepoint
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Baseline and 8 week after baseline
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Method of measurement
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Waist circumference, body mass index (kg/m2), and waist to hip ratio
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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TBZMED.REC.1394.518
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Just a part of data can share.
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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There is no limitation.
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Under which criteria data/document could be used
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There is no limitation.
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From where data/document is obtainable
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E-mail: pirouzpanah@gmail.com
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What processes are involved for a request to access data/document
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After sending a written request via e-mail, the files will be sent.
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Comments
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