TCTR20170314001CompletedPhase 2
Effect of probiotics for the prevention of acute radiation-induced diarrhoea among cervical cancer patients: a randomized double-blind placebo-controlled study
Self funded0 sites57 target enrollmentStarted: March 14, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 57
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 0 N/A (No limit) (—)
- Sex
- Female
Inclusion Criteria
- •1. Patients with the cervical cancer (FIGO staging †I B and above) who will receive external beam radiotherapy for a minimum of 40 Gy at pelvis level with or without concurrent chemotherapy
- •2. Age †above 18 years
- •3. Patients with the ECOG performance status (0-2)
Exclusion Criteria
- •1. Patients with the previous history of pelvic radiotherapy
- •2. Patients with the history of intestinal resection
- •3. Patients with the medical history of irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease and ileostomy
- •4. Patients with the history of daily use of antidiarrhoeal medication before radiotherapy
- •5. Patients with diarrhoea at the beginning of study
- •6. Patients with immunosuppression (HIV positive, immunosuppressive drugs)
- •7. Patients with structural heart diseases and those with prosthetic heart valves
Investigators
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