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

NCT06783153 | Not Yet Recruiting Phase 1

• 1 other identifier: 2023-238
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Drug: Standard Care Chemoradiation

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

EXPERIMENTAL

Drug: Rifaximin 550 MG

Interventions

Rifaximin 550 MG 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.

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

Standard Care Chemoradiation DRUG

Patients will receive standard chemotherapy and/or radiation

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Province, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Rectal Neoplasms

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Noha Mansour

CONTACT

01221611667; nohamansaur@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professsor

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

EG (1)