About this trial
Patients treated for gynecological tumors with radiotherapy (RT) and/or chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.
Eligibility criteria
Qualifiers
Adult women (>=18 years).
Diagnosed with gynecological tumors (any location and stage).
Previously treated with radiotherapy and/or chemotherapy.
Must accept and sign the specific informed consent for this study.
Disqualifiers
Not meeting all inclusion criteria.
Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.
Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.
Unwillingness or inability to provide written informed consent for study participation.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Bernardino Clavo, MD, PhD
Lead sponsor
Dr. Negrin University Hospital
Sponsor institution
Dr. Negrin University Hospital
Collaborator
Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI)
Collaborator
Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Collaborator
Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna
Collaborator
Centers for International Business Education and Research
Collaborator