Radiotherapy Induced Diarrhea, Acute Radiation Enteritis, Prostate Cancer, Cervical Adenocarcinoma, Bladder (Urothelial, Transitional Cell) Cancer, Rectal Adenocarcinoma, Pelvic Radiotherapy, Rifaximin
Conditions
Brief summary
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.
Interventions
DRUGRifaximin 550 MG
Oral 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.
Patients will receive standard chemotherapy and/or radiation
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Patients experiencing diarrhea at the outset of the study. * Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications. * Pregnant or lactating woman. * Patients allergic to rifamycin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 12 months |
Countries
Egypt
Contacts
Primary ContactNoha Mansour
Outcome results
None listed