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

NCT ID: NCT06783153

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Arm

Group Type: ACTIVE_COMPARATOR

Standard Care Chemoradiation

Intervention Type: DRUG

Patients will receive standard chemotherapy and/or radiation

Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapy

Group Type: EXPERIMENTAL

Rifaximin 550 MG

Intervention Type: DRUG

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.

Interventions

Rifaximin 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.

Intervention Type: DRUG

Standard Care Chemoradiation

Patients will receive standard chemotherapy and/or radiation

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Noha Mansour

Associate professsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University

Al Mansurah, Province, Egypt

Countries

Egypt

Central Contacts

Noha Mansour

Role: CONTACT

nohamansaur@mans.edu.eg

01221611667

Facility Contacts

Noha Mansour

Role: primary

nohamansaur@mans.edu.eg

01221610667

Noha Mansour

Role: backup

Other Identifiers

2023-238

Identifier Type: -

Identifier Source: org_study_id