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Effect of symbiotic supplement on breast cancer recurrence

Not Applicable
Conditions
Breast cancer.
Malignant neoplasm of breast
C50-C50
Registration Number
IRCT2015090223861N1
Lead Sponsor
Vice chancellor of research, Iran University of Medical Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
76
Inclusion Criteria

Inclusion criteria :
1- Female breast cancer survivors (or Cessation of menstruation for at least 6 months prior to chemotherapy); 2- Age range (50-75); 3- BMI = 25 - 40 Kg/m2; 4- At least one month has passed since the last radiotherapy; 5- Complete treatment of stage 1 - 4 breast cancer survivors; 6- Type of breast cancer : ER/PR+ and HER2-; 7- Willingness to cooperate and sign a written informed consent

Non-inclusion criteria:
1- History of Diabetes, acute heart failure, cirrhosis hepatic, acute and chronin renal failure; 2- History of autoimmune and infectious disease; 3- Have a weight loss diet during the 6 months prior to study; 4- Smoking; 5- Alcohol consumption; 6- Nutrition supplement consumption

Exclusion criteria :
1- Metastasis during the study; 2- Failure to follow the weight loss diet; 3-Consumption less than 46 capsules of 56 capsules at the end of study; 4-Infectious disease during the study; 5- Consumption of probiotic foods during the study; 6- Consumption of fibre supplement during the study; 7- Consumption of herbal supplement; 8- Patient at any time can leave the study freely

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Concentration of fasting serum Insulin. Timepoint: Before intervention and 8weeks after the start of intervention. Method of measurement: Microunit/ml - Elisa method.
Secondary Outcome Measures
NameTimeMethod
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