About this trial
Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.
Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.
Disqualifiers
Patients who have a record of intestinal resection in their medical history.
Patients with a medical background of irritable bowel syndrome.
Patients with a history of inflammatory bowel disease.
Patients who regularly take anti-diarrheal medications before commencing radiotherapy.
Trial design
Parallel
Treatments tested in this trial
Rifaximin 550 MG
DrugOral Rifaximin 550mg twice daily from the start of pelvic radiotherapy, with or without chemotherapy, as a preventive measure, and continuing every day until the end of the treatment up to 5 to seven weeks.
Standard Care Chemoradiation
DrugPatients will receive standard chemotherapy and/or radiation
Treatment groups
Trial outcomes
Primary outcomes
The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation.
Sponsors and contacts
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