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

Mansoura University

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Rifaximin

Pelvic Radiotherapy

Rectal Adenocarcinoma

Cervical Adenocarcinoma

Radiotherapy Induced Diarrhea

Prostate Cancer

Bladder (Urothelial, Transitional Cell) Cancer

Acute Radiation Enteritis

Treatments

Drug: Standard Care Chemoradiation

Drug: Rifaximin 550 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT06783153

2023-238

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.