Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rifaximin 550 MG, Standard Care Chemoradiation.
- Who it may be relevant to
- Registry conditions: Radiotherapy Induced Diarrhea, Acute Radiation Enteritis, Prostate Cancer, Cervical Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 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. - Drug Standard Care Chemoradiation
Patients will receive standard chemotherapy and/or radiation
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Mansoura University — Al Mansurah
Identifiers
NCT: NCT06783153 · 2023-238