Effect Of Coenzyme Q10 Supplementation On Serum LevelsOf Interleukin 6, 8, Vascular Endothelial Growth Factor And Quality Of Life In Breast Cancer Women Undergoing Tamoxifen Therapy
Objective:Effect of co enzyme Q10 supplementation on serum levels of interleukin 6, 8, vascular endothelial growth factor and quality of life in breast cancer women undergoing tamoxifen therapy
Study design: Randomized, double-blind(blinding for patients and scholar), placebo controlled
The study population:
Inclusion criteria : diagnosed with positive estrogen receptor breast cancer by a physician; chemotherapy and radiation therapy, and a history of taking tamoxifen for at least a year; Not taking Q10 supplement and other antioxidants such as vitamin E; Willingness to comply with all interventions and follow-up procedures; Non-pregnant and non-lactating; Having no uncontrolled diseases such as diabetes and thyroid; Not taking non-prescription drugs, corticosteroids, statins
Exclusion criteria : metastasis; partial or total mastectomy and not having any of the above entry criteria
Sample size: 60
Intervention or interference in the study: Effect of co enzyme Q10 on serum levels of interleukin 6, 8, vascular endothelial growth factor and quality of life
Intervention time: 2 months
The primary outcome or consequences of the study: variation of serum interleukin 6 and 8, VEGF and quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042021874N1
Registration date:2015-10-08, 1394/07/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-08, 1394/07/16
Registrant information
Name
Nazanin Zahrooni
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 7587
Email address
zahrooni.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition and Metabolic Disorders Research Center
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Coenzyme Q10 Supplementation On Serum LevelsOf Interleukin 6, 8, Vascular Endothelial Growth Factor And Quality Of Life In Breast Cancer Women Undergoing Tamoxifen Therapy
Public title
The effect of Q10 on breast cancer treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : diagnosed with positive estrogen receptor breast cancer by a physician; chemotherapy and radiation therapy, and a history of taking tamoxifen for at least a year; Not taking Q10 supplement and other antioxidants such as vitamin E; Willingness to comply with all interventions and follow-up procedures; Non-pregnant and non-lactating; Having no uncontrolled diseases such as diabetes and thyroid; Not taking non-prescription drugs, corticosteroids, statins
Exclusion criteria : metastasis; partial or total mastectomy and not having any of the above entry criteria
Age
From 19 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
No other
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Ahvaz Medical University
Street address
Clinical trial research center,Jondi-shapoor Medical University of Ahvaz
City
Ahvaz
Postal code
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
ir.ajums.rec.1394.246
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C44.5,C50.
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Quten serum levels
Timepoint
Before intervention
Method of measurement
Pg/ml using biochemical kits
2
Description
Interluekin 6 serum levels
Timepoint
Before and after intervention
Method of measurement
Pg/ml using biochemical kits
3
Description
Interluekin 8 serum levels
Timepoint
Before and after intervention
Method of measurement
Pg/ml using biochemical kits
4
Description
VEGF serum levels
Timepoint
Before and after intervention
Method of measurement
Pg/ml using biochemical kits
5
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Breast cancer Quality of Life Questionnaire
Secondary outcomes
1
Description
weight
Timepoint
Before and after intervention
Method of measurement
Scale
2
Description
Dietary intake
Timepoint
Before and after intervention
Method of measurement
Three-day record
Intervention groups
1
Description
Intervention group of patients: 100 mg Q10 daily for 2 months
Category
Treatment - Drugs
2
Description
Intervention group of non patients: 100 mg Q10 daily for 2 months
Category
Treatment - Drugs
3
Description
Control group of patients: placebo for 2 months
Category
Treatment - Drugs
4
Description
Control group of non patients: placebo for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr.Ahmad Ahmadzadeh
Street address
Shafa Hospital, Golestan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Research Center office, Research and Technology Center, Ahvaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ahvaz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Nutrition and Metabolic Disorders Research Center
Full name of responsible person
Dr.Seyed Ahmad Hosseini
Street address
Second floor, Paramedical Faculty, Ahwaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?