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Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)

Recruitingn/aAges 18 Years - anyFemaleBernardino Clavo, MD, PhD
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In plain words

What the trial is, and whether it could suit you

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 sever

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📋 Eligibility rules (as published)
Inclusion Criteria for all patients (Cases and Controls): 1. Adult women (\>=18 years). 2. Diagnosed with gynecological tumors (any location and stage). 3. Previously treated with radiotherapy and/or chemotherapy. 4. Must accept and sign the specific informed consent for this study. Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases): 5. Must present chronic TPIRQT with \>= 3 months of duration after habitual symptomatic treatment. 6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale. Exclusion Criteria for all patients (Cases and Controls): 1. Not meeting all inclusion criteria. 2. 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. 3. 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. 4. Unwillingness or inability to provide written informed consent for study participation.
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What it tests

  • Not listed
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Where

2 sites
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas de Gran Canaria, Spain
Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias - Universidad de La Laguna
San Cristóbal de La Laguna, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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