Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients

Phase 2Not Yet RecruitingNCT06783153

Mansoura University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Radiotherapy Induced Diarrhea Acute Radiation Enteritis Prostate Cancer Cervical Adenocarcinoma Bladder (Urothelial, Transitional Cell) Cancer

Interventions

Rifaximin 550 MGDRUG

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.

Standard Care ChemoradiationDRUG

Patients will receive standard chemotherapy and/or radiation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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.

Time frame: 12 months