Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treat… (NCT07259681) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
Spain38 participantsStarted 2026-01-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. Must present chronic TPIRQT with \>= 3 months of duration after habitual symptomatic treatment.
✓. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.
Exclusion criteria
✕. 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.
What they're measuring
1
Comparison of gut microbiome profile (composition and diversity) between TPIRQT and Control groups
Timeframe: Baseline (single time point for controls, pre-ozone for cases)
2
Change in gut microbiome profile (composition and diversity) in patients with TPIRQT after rectal ozone therapy.