Gut microbiome in gynecologic cancer patients with pelvic toxicity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will explore the relationship between gut microbiome composition and diversity, the presence and severity of pelvic toxicity after radiotherapy and/or chemotherapy, and the response to rectal ozone therapy. It includes adult women with gynecologic cancers who have previously received RT/CT, with cases having chronic pelvic toxicity of at least 3 months and CTCAE grade 2 or higher. By comparing patients with and without pelvic toxicity, the study aims to identify microbiome patterns associated with TPIRQT and to see if ozone therapy correlates with shifts in gut microbiota. No interventional treatment beyond the standard use of rectal ozone therapy is described, and all participants provide informed consent. Results could shed light on potential microbiome-related mechanisms and guide future therapeutic strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
  Las Palmas de Gran Canaria, Las Palmas, Spain Recruiting
• Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias - Universidad de La Laguna
  San Cristóbal de La Laguna, Tenerife, Spain Recruiting

Study contacts

• Principal investigator: Jacob Lorenzo-Morales, Prof — Instituto Universitario de Enfermedades Tropicales y Salud Publica de Canarias, Universidad La Laguna
• Study coordinator: Bernardino Clavo, MD, PhD
• Email: bernardinoclavo@gmail.com
• Phone: 34928449278

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.