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NCT Number: NCT06783153

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

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.

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Key information

Conditions

Radiotherapy Induced Diarrhea Acute Radiation Enteritis Bladder (Urothelial, Transitional Cell) Cancer Cervical Adenocarcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Pelvic Radiotherapy Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Adenocarcinoma Rectal Diseases Rectal Neoplasms Rifaximin Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mansoura University

Al Mansurah, Province, 35516, Egypt

Location contact

Noha Mansour

CONTACT

[email protected]

01221610667

Noha Mansour

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard Care Chemoradiation

Drug

Patients will receive standard chemotherapy and/or radiation

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.

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Noha Mansour

CONTACT

[email protected]

01221611667

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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