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The Effects of synbiotic supplementation in reducing of Chemotherapy-induced side effects in women with Breast Cancer

Phase 3
Recruiting
Conditions
chemotherapy-induced side effects.
Registration Number
IRCT20091114002709N56
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
72
Inclusion Criteria

Definitive diagnosis of breast cancer by oncologist and pathologist
Receiving one-day chemotherapy courses
Stage 1 to 3 of breast cancer (pre-metastatic stages)
History of complications following previous chemotherapy sessions
no history of gastrointestinal problems before breast cancer
at least one and at last two previous sessions of chemotherapy
Do not consuming probiotic dairy products or any foods containing probiotic or prebiotic compounds, or their supplements in the past two weeks.
Age 18 years and older
Willingness to cooperation

Exclusion Criteria

Chronic diseases such as hypertension, coronary heart disease, history of stroke, liver failure (ALT and AST levels > 100 IU / L), renal failure (serum creatinine levels > 1.7 mg / dl), impaired cell count (WBC > 20,000 U / L, hemoglobin less than 10 mg / dl, platelets <15,000 / mcL or >400,000 / mcL) and gastrointestinal problems
Body mass index >30 kg / m2
History of tumor in other organs or metastasis to other organs
taking medicines or other treatments to reduce nausea (Except for the usual anti-nausea and vomiting medicines)
Severe gastrointestinal problems and complications during the study
Neutropenic patients
Consumption of probiotic dairy products or any foods containing probiotic or prebiotic compounds, or their supplements during the study
Recent infection or recent use of antibiotics in the past three months
Receiving radiation therapy and chemotherapy simultaneously
Not willing to continue cooperation

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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