The effects of Lactobacillus acidophilus probiotic capsule administration on the immune system and treatment efficacy in patients with rectal cancer
Phase 3
Recruiting
- Conditions
- locally advanced rectal cancer.Malignant neoplasm of rectum
- Registration Number
- IRCT2016061118745N8
- Lead Sponsor
- Vice Chancellor for research of Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Inclusion criteria : Patient with locally advanced rectal cancer ; Patient with non-metastatic rectal cancer; Voluntary participation in the study and informed consent form fulfilling; Lack of swallowing disorder.
Exclusion criteria : Patients with other cancers; Patients with renal and hepatic disorders; Patients with intestinal obstruction; Patients with low level of white blood cells (less than 1000 cells per mm3); Patients with drug intolerance or drug sensitivity to probiotics.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Destroy of tumor or decrease of tumor size. Timepoint: The beginning and end of the study. Method of measurement: CT.
- Secondary Outcome Measures
Name Time Method STAT4 gene expression. Timepoint: The beginning and end of the study. Method of measurement: Real-time PCR.;The serum levels of cytokines. Timepoint: The beginning and end of the study. Method of measurement: ELISA technique.;CDs measurement. Timepoint: The beginning and end of the study. Method of measurement: Flowcytometry.