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The effect of synbiotic supplementation on inflammation in Breast Cancer survivors with Lymphedema

Phase 2
Recruiting
Conditions
lymphedema.
Breast, unspecified
Registration Number
IRCT2017092023861N7
Lead Sponsor
Vice chancellor of research, Iran University of Medical Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
88
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

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Tumor necrosis factor alpha. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA.
Secondary Outcome Measures
NameTimeMethod
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