Cancer
Conditions
Keywords
probiotics, intestinal microbiome, radiotherapy
Brief summary
The purpose of this study is to evaluate the effect of probiotics to improve the intestinal microbiome in malignancy patients who get pelvic/abdominal radiotherapy.
Detailed description
Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates changes in bacterial microbiome, the vascular permeability of the mucosal cells and in intestinal motility. Probiotics were known to improve gastrointestinal function. This is a randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate the effect of probiotics to change the intestinal microbiome in in patients undergoing concurrent pelvic/abdominal RT.
Interventions
DIETARY_SUPPLEMENTprobiotics (six probiotic cultures)
Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.
DIETARY_SUPPLEMENTPlacebo
Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who current diagnosis of gynecologic cancer or rectal cancer and never previously received radiation therapy and will use for the first time radiotherapy at department of radiation oncology, Seoul National University Hospital. * ECOG performance status (PS) of 0, 1, or 2. * signed written informed consent. * Patients who get pelvic/abdominal radiotherapy.
Exclusion criteria
* People who use antibiotics that can affect intestinal microorganism growth within one month before the study. * Patients who use probiotics within one month before the study. * Patients received neoadjuvant chemotherapy. * Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient. * Patients diagnosed with inflammatory bowel disease. * Patients suspected gastrointestinal infections and other infectious diseases. * Suspected infections from blood tests : Excessive rise in WBC, ESR, CRP * Suspected renal insufficiency from blood tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy. | 42 days | * Comparison of overall microbial communities in fecal samples between probiotics treated patients and control cancer patients receiving radiation therapy. * To determine preventing effect of probiotics against radiation enteropathy, all the bacterial species level taxon derived from fecal samples of cancer patients will be identified by massive sequencing analysis and relative abundance of each taxon between two groups will be statistically compared. * In addition, overall microbial composition, kind of species and their abundance, in two groups will be compared with clustering method such as UPGMA and PCoA and the variation values between two groups will be calculated. * In the current study, we will determine the effectiveness of probiotics for the prevention of radiation induced complications with these two comparative analysis methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of any grade of diarrhea and gastrointestinal symptoms | 42 days | * Gastrointestinal symptoms will be scored according the Gastrointestinal symptom rating scale before and after RTx. * Diarrhea will be graded weekly according the Common Toxicity Criteria system. |
Countries
South Korea
Contacts
Primary ContactHak Jae Kim, MD
Backup ContactSeung Wan Kang, MD,PhD
Outcome results
None listed