he Effects of probiotic supplementation on related side effects after chemotherapy laboratory symptoms and in metastatic gastrointestinal cancer
Phase 3
Recruiting
- Conditions
- GI Metastatic Cancer.Personal history of malignant neoplasm
- Registration Number
- IRCT20240629062278N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
65-18 years old with metastatic GI cancer undergoing chemotherapy
No lactose intolerance
Did not have any symptoms of diarrhea, constipation, nausea, vomiting, or mucositis before receiving chemotherapy,
Functional status 0 or 1 according to ECOG (Eastern Cooperative Oncology Group)
Exclusion Criteria
Reluctance of the patient to participate in the study
Description of underlying diseases including IBD
\History of Colectomy
Taking any antibiotic or other drugs
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Examination of gastrointestinal symptoms: examination of changes in the severity of symptoms up to three chemotherapy courses (equivalent to 3 months) compared to zero time. Timepoint: Zero time & 3 months later. Method of measurement: The severity of diarrhea is described using the CTCAE Common Terms for Adverse Events criteria (NCI, National Cancer Institute). The severity of mucositis according to the CTCAE criteria.The type and severity of constipation based on the criteria (BRISTOL BSFS).;Examining inflammatory factors and tumor markers: Examining the changes three and six months after the intervention compared to zero time. Timepoint: Zero time, 3 and 6 months later. Method of measurement: laboratory evaluation.
- Secondary Outcome Measures
Name Time Method