Study of radioprotective effects of oral dose vitamin c to mitigate lymphocytopenia in patient undergoing radiotherapy for breast cancer
Design
3 groups of 20 people that include a control group and groups are parallel, double blind, randomized
Settings and conduct
Patients in the Namazi Hospital are asked to take 4 hours after each radiotherapy session to take vitamin C which are blinded and three times to receive blood samples, then lymphocyte count and total antioxidant capacity are investigated
Participants/Inclusion and exclusion criteria
Entry requirements for breast cancer and the need for radiotherapy after mastectomy
Exit Conditions Study the history of kidney disease and kidney stones and the use of multivitamins
Intervention groups
Oral doses of 150 and 250 mg of vitamin C and placebo of vitamin C
Main outcome variables
Counting lymphocytes, Mitigation lymphocytopenia in patient undergoing radiotherapy for breast cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161007030196N2
Registration date:2018-11-12, 1397/08/21
Registration timing:registered_while_recruiting
Last update:2018-11-12, 1397/08/21
Update count:0
Registration date
2018-11-12, 1397/08/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32308113
Email address
stud6190006825@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-01, 1397/08/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of radioprotective effects of oral dose vitamin c to mitigate lymphocytopenia in patient undergoing radiotherapy for breast cancer
Public title
effects of vitamin c to mitigation the incidence of in patient undergoing radiotherapy for breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
breast cancer
The need for radiotherapy after mastectomy
Exclusion criteria:
The history of kidney disease and kidney stones
The use of multivitamins
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simplified randomization method is with a dice. Dicing for each person, if the number is1 or 2 then the person is placed in group A and if 3-4 in group B and if number 5-6 in group C and then they are divided into three equal groups. There are two intervention groups and one placebo group, and the names are hidden inside sealed envelopes by someone except the researcher (like Hospital Collaborator).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers and clinical caregivners have been two-way blinded to the study groups using randomize.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice_Chanceller for Research and Technology ,Seventh Floor ,Central Building of Shiraz University of Medical Sciences ,Zand street
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ ۷۱۳۴۸
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
1397.410
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
Counting peripheral blood lymphocytes
Timepoint
Before entering the study, on days 14 and 28 after starting taking vitamin C
Method of measurement
Isolation of lymphocytes by centrifuge and counting by microscope
Secondary outcomes
1
Description
total antioxidant capacity
Timepoint
Before starting the intervention and day 28 after taking vitamin C
Method of measurement
Using the Eliza 96 Kit
Intervention groups
1
Description
Intervention group:
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hosppital
Full name of responsible person
dr.seyed mohammad javad mortazavi
Street address
Namazai Square ,Zand Avenue ,Namazi Hospital
City
Shiraz
Province
Fars
Postal code
11351_71937
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr.seyed mohammad javad mortazavi
Street address
Central Building of Shiraz University of Medical Sciences , Facing Palestine Street ,Zand Streetet
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
dr.seyed mohammad javad mortazavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Department of Physics and Medical Engineering, Seventh Floor ,Building No.3 ,Faculty of Medicine ,Karim Khan Zand Street
City
Shiraz
Province
Fars
Postal code
71348455794
Phone
+98 71 3208 3366
Email
mmortazavi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr.seyed mohammad javad mortazavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Department of Physics and Medical Engineering, Seventh Floor ,Building No.3 ,Faculty of Medicine ,Karim Khan Zand Street
City
Shiraz
Province
Fars
Postal code
71348455794
Phone
0098
Email
mmortazavi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr.seyed mohammad javad mortazavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Department of Physics and Medical Engineering, Seventh Floor ,Building No.3 ,Faculty of Medicine ,Karim Khan Zand Street
City
Shiraz
Province
Fars
Postal code
71348455794
Phone
+98 71 3208 3366
Email
mmortazavi@sums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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