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

Phase 1

Not yet recruiting

• Conditions: Radiotherapy Induced Diarrhea; Acute Radiation Enteritis; Prostate Cancer; Cervical Adenocarcinoma; Bladder (Urothelial, Transitional Cell) Cancer; Rectal Adenocarcinoma; Pelvic Radiotherapy; Rifaximin
• Interventions: Drug: Standard Care Chemoradiation; Drug: Rifaximin 550 MG

• Registration Number: NCT06783153
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study Start: 2025-01-20
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Standard Care Chemoradiation	-
Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapy	Rifaximin 550 MG	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Province, Egypt