Specific objective of this study is The effect of synbiotic supplementation on the serum concentration of inflammatory cytokines and leptin in Breast Cancer survivors with Lymphedema. Method : randomized, double blind, consumption of placebo in control group, single center. participants: breast cancer survivors with lymphedema. Inclusion criteria: women with unilateral breast cancer related lymphedema ; breast cancer lymphedema in stage 2 ; Age range between 18 to 60 years; BMI between 25 to 35 Kg/m2 ; At least one month has passed since the last treatment such as radiotherapy. Exclusion criteria: Cancer recurrence during the study; Metastasis; Diseases leading to edema such as renal, cardiopulmonary and pulmonary failure during the study; Infectious diseases during the study; Consumption of food and supplements containing probiotics during the study; Failure to follow the weight loss diet; Consumption less than 56 capsules. Sample size of this study is 88 persons (44 individuals in intervention group and 44 individuals in control 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 38.5 mg fructooligosaccharide, once daily for 10 weeks in breast cancer survivors with low calorie diet. Primary outcome of this study is Tumor necrosis factor alpha and secondary outcomes are interleukin 1 ; interleukin 6 ; hsCRP and leptin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092023861N7
Registration date:2017-10-25, 1396/08/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-25, 1396/08/03
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 synbiotic supplementation on the serum concentration of inflammatory cytokines and leptin in Breast Cancer survivors with Lymphedema
Public title
The effect of synbiotic supplementation on inflammation in Breast Cancer survivors with Lymphedema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with unilateral breast cancer related lymphedema ; breast cancer lymphedema in stage 2; Age range between 18 to 60 years ; BMI between 25 to 35 Kg/m2 ; At least one month has passed since the last treatment such as radiotherapy; Willingness to participate in the study ; Non-inclusion 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; Exclusion criteria: Cancer recurrence during the study; Metastasis; Diseases leading to edema such as renal, cardiopulmonary and pulmonary failure during the study; Infectious diseases during the study; Consumption of food and supplements containing probiotics during the study; Failure to follow the weight loss diet; Consumption less than 56 capsules; Unwillingness to continue cooperation
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
For randomization, the permuted block randomization will be used with quadruple blocks. According to the sample size of 88 identified, 22 blocks will be produced using the online site (www.sealedenvelope.com). In order to apply the concealment in the randomization process, unique codes will be used on the pharmaceutical boxes, which will be generated by the software. By entering each individual into a study based on the sequence produced, the packet of the drug in which the code is registered will be assigned to the individual. During the research, the random list has been provided to the statistics consultant and patients, executor of plan and everybody who takes part in measuring indicators will not be informed of the assigned groups.
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 1396.9511468008
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
Tumor necrosis factor alpha
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
interleukin 1
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
ELISA
2
Description
interleukin 6
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
ELISA
3
Description
leptin
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
ELISA
4
Description
hsCRP
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
immunoturbidimetry
5
Description
volume of lymphedema
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
water tank technique
6
Description
BMI
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
Weight ratio (kg) to squared height (m)
7
Description
waist circumference
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
meter
8
Description
waist to hip ratio
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
Calculate
9
Description
skinfold thickness
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
caliper
10
Description
Nutritional status
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer
11
Description
Physical Activity
Timepoint
Before intervention and 10 weeks after the start of intervention
Method of measurement
IPAQ 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) + 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) + placebo consists of ( lactose,Magnesium Stearate, talk, 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
Dr Mitra Zarrati
Street address
Fourth Unit, Second Floor, Building 17, next to Kalantari, South Aboozar St, Khajeh Abdollah Ansari St, Seyed khandan Bridge.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Iran University of Medical Science
Full name of responsible person
Seyed Ali Javad Moosavi, Assistant of Research and Technology , Iran University of Medical Sciences
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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of 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 Science
Full name of responsible person
Dr Mitra Zarrati
Position
Assistant Professor
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
+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
Full name of responsible person
Dr Mitra Zarrati
Position
Assistant Professor
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
+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
Full name of responsible person
Saeideh Vafa
Position
MS.c student in Nutrition Science
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
saeideh.sv90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)