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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Control ArmActive comparator 1 intervention
Group B: Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapyExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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