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The effect of symbiotic supplementation on superoxide dismutase and malondialdehyde in breast cancer-related lymphedema

Protocol summary

Summary
Specific objective of this study is effect of symbiotic supplementation on antioxidant capacity in breast cancer-related lymphedema. Method: randomized, double blind, placebo controlled, single center trial. Participants: Women with breast cancer-related lymphedema. Inclusion criteria: women with unilateral breast cancer related lymphedema, breast cancer lymphedema in stage 2, Age range 18-60, BMI = 25 - 35 Kg.m2, At least one month has passed since the last treatment such as radiotherapy. Exclusion criteria: Cancer recurrence during the study, Failure to follow the weight loss diet, Consumption of food and supplements containing probiotics during the study, Diseases leading to edema such as renal, cardiopulmonary and during the study, Metastasis, Consumption less than 56 capsules. Sample size of this study is 88 persons (44 persons per group). Intervention in this study is consumption of synbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) microbal population : 1010 CFU.gr and 5.38 mg Fructooligosaccharide, once daily for 10 weeks in breast cancer survivors with low calorie diet. Primary outcome of this study are change in Superoxide Dismutase and Malondialdehyde and secondary outcomes are change in Total Antioxidant Capacity and Glutathione Peroxidase.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092323861N8
Registration date: 2017-11-20, 1396/08/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Mitra Zarrati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4814
Email address
zarrati.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Science
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of symbiotic supplementation on superoxide dismutase and malondialdehyde in breast cancer-related lymphedema
Public title
The effects of synbiotic supplemention on antioxidant capacity in breast cancer-related lymphedema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with unilateral breast cancer related lymphedema; breast cancer lymphedema in stage 2; Age range 18-60, BMI = 25 - 35 Kg.m2; At least one month has passed since the last treatment such as radiotherapy; Willingness to participate in the study and sign a written informed consent. Exclusion criteria: Use of multivitamin minerals and omega 3 supplements up to 1 month before the study began; Inflammatory diseases such as heart failure, pulmonary, kidney and diabetes; autoimmune diseases such as rheumatoid arthritis; Acute and chronic infection; taking Probiotics supplementation from 6 months before study; having a weight loss diet in Length 6 months before the study ; Smoking and Alcohol consumption; Lymphedema due to other cancers
Age
From 18 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Hemmat expressway
City
Tehran
Postal code
1449614535
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511323007

Health conditions studied

1

Description of health condition studied
lymphedema
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified

Primary outcomes

1

Description
Superoxide Dismutase, Malondialdehyde
Timepoint
before and after intervantion
Method of measurement
Colorimetric, Colorimetric/ Fluorometric

Secondary outcomes

1

Description
Total Antioxidant Capacity
Timepoint
before and after intervantion
Method of measurement
Colorimetric

2

Description
Glutathione Peroxidase
Timepoint
before and after intervantion
Method of measurement
Colorimetric

3

Description
volume of lymphedema
Timepoint
before and after intervantion
Method of measurement
tank water

4

Description
BMI
Timepoint
before and after intervantion
Method of measurement
formula

5

Description
Waist circumference
Timepoint
before and after intervantion
Method of measurement
meter

6

Description
Waist to hip ratio
Timepoint
before and after intervantion
Method of measurement
formula

7

Description
Skinfold thickness
Timepoint
before and after intervantion
Method of measurement
caliper

8

Description
Nutritional status
Timepoint
before and after intervantion
Method of measurement
Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer

9

Description
Physical Activity
Timepoint
before and after intervantion
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: Weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure, should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Calorie intake of participants is calculated base on Mifflin Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + consumption of synbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) Microbal population: 1010 CFU/gr and 38/5 mg Fructooligosaccharide, once daily for 10 weeks. synbiotic supplement will be purchase from Zist takhmir company.
Category
Treatment - Drugs

2

Description
Control group: weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure, should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Calorie intake of participants is calculated based on Mifflin Formula. The recommended amount of calories from each nutrient during the day will be based on: carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + placebo consists of ( lactose, Magnesium Stearate, Talc, Silicon Dioxide) once daily for 10 weeks. Placebo will be purchase from Zist takhmir company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed Khandan Physiotherapy Clinic
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Science
Full name of responsible person
Doctor seyed Javad ali Mosavai
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
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, Iran University of Medical Science
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
Iran University of Medical Sciences, School of Public Health
Full name of responsible person
Mitra Zarrati
Position
Assistant Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
+98 21 8670 4814
Fax
Email
zarrati.m@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Public Health
Full name of responsible person
Mitra Zarrati
Position
Assistant Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
+98 21 8670 4814
Fax
Email
zarrati.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Public Health
Full name of responsible person
Mehraban Navaei
Position
MS.c student in public health Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
00
Fax
Email
mehr4nava@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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