Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
NCT ID: NCT07259681
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
38 participants
OBSERVATIONAL
2026-01-15
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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TPIRQT Group (Cases)
Patients with gynecological tumors treated with RT and/or CT who develop chronic pelvic toxicity (TPIRQT) and are referred for compassionate-use rectal ozone therapy at the Chronic Pain Unit. Samples and data will be collected before and after ozone therapy
No interventions assigned to this group
Control Group
pelvic toxicity (TPIRQT). This group will be matched by age (± 5 years) and primary tumor location. Samples and data will be collected once during a follow-up visit.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
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.
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.
18 Years
FEMALE
No
Sponsors
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Dr. Negrin University Hospital
OTHER
Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI)
UNKNOWN
Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
OTHER
Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna
UNKNOWN
CIBER (Infectious diseases)
UNKNOWN
Bernardino Clavo, MD, PhD
OTHER
Responsible Party
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Bernardino Clavo, MD, PhD
Principal Investigator, Research Unit Director
Principal Investigators
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Bernardino Clavo, MD, PhD
Role: STUDY_CHAIR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Jacob Lorenzo-Morales, Prof
Role: PRINCIPAL_INVESTIGATOR
Instituto Universitario de Enfermedades Tropicales y Salud Publica de Canarias, Universidad La Laguna
Francisco Rodríguez-Esparragón, BSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Locations
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Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas de Gran Canaria, Las Palmas, Spain
Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias - Universidad de La Laguna
San Cristóbal de La Laguna, Tenerife, Spain
Countries
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Central Contacts
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Facility Contacts
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Bernardino Clavo, MD, PhD
Role: primary
Francisco Rodríguez-Esparragón, BSc, PhD
Role: backup
Jacob Lorenzo-Morales, Prof
Role: primary
References
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Clavo B, Canovas-Molina A, Ramallo-Farina Y, Federico M, Rodriguez-Abreu D, Galvan S, Ribeiro I, Marques da Silva SC, Navarro M, Gonzalez-Beltran D, Diaz-Garrido JA, Cazorla-Rivero S, Rodriguez-Esparragon F, Serrano-Aguilar P. Effects of Ozone Treatment on Health-Related Quality of Life and Toxicity Induced by Radiotherapy and Chemotherapy in Symptomatic Cancer Survivors. Int J Environ Res Public Health. 2023 Jan 13;20(2):1479. doi: 10.3390/ijerph20021479.
Clavo B, Navarro M, Federico M, Borrelli E, Jorge IJ, Ribeiro I, Rodriguez-Melcon JI, Carames MA, Santana-Rodriguez N, Rodriguez-Esparragon F. Long-Term Results with Adjuvant Ozone Therapy in the Management of Chronic Pelvic Pain Secondary to Cancer Treatment. Pain Med. 2021 Sep 8;22(9):2138-2141. doi: 10.1093/pm/pnaa459. No abstract available.
Clavo B, Navarro M, Federico M, Borrelli E, Jorge IJ, Ribeiro I, Rodriguez-Melcon JI, Carames MA, Santana-Rodriguez N, Rodriguez-Esparragon F. Ozone Therapy in Refractory Pelvic Pain Syndromes Secondary to Cancer Treatment: A New Approach Warranting Exploration. J Palliat Med. 2021 Jan;24(1):97-102. doi: 10.1089/jpm.2019.0597. Epub 2020 May 5.
Clavo B, Santana-Rodriguez N, Llontop P, Gutierrez D, Ceballos D, Mendez C, Rovira G, Suarez G, Rey-Baltar D, Garcia-Cabrera L, Martinez-Sanchez G, Fiuza D. Ozone Therapy in the Management of Persistent Radiation-Induced Rectal Bleeding in Prostate Cancer Patients. Evid Based Complement Alternat Med. 2015;2015:480369. doi: 10.1155/2015/480369. Epub 2015 Aug 18.
Clavo B, Ceballos D, Gutierrez D, Rovira G, Suarez G, Lopez L, Pinar B, Cabezon A, Morales V, Oliva E, Fiuza D, Santana-Rodriguez N. Long-term control of refractory hemorrhagic radiation proctitis with ozone therapy. J Pain Symptom Manage. 2013 Jul;46(1):106-12. doi: 10.1016/j.jpainsymman.2012.06.017. Epub 2012 Oct 26.
Wang A, Ling Z, Yang Z, Kiela PR, Wang T, Wang C, Cao L, Geng F, Shen M, Ran X, Su Y, Cheng T, Wang J. Gut microbial dysbiosis may predict diarrhea and fatigue in patients undergoing pelvic cancer radiotherapy: a pilot study. PLoS One. 2015 May 8;10(5):e0126312. doi: 10.1371/journal.pone.0126312. eCollection 2015.
Wang L, Wang X, Zhang G, Ma Y, Zhang Q, Li Z, Ran J, Hou X, Geng Y, Yang Z, Feng S, Li C, Zhao X. The impact of pelvic radiotherapy on the gut microbiome and its role in radiation-induced diarrhoea: a systematic review. Radiat Oncol. 2021 Sep 25;16(1):187. doi: 10.1186/s13014-021-01899-y.
Li L, Yang Z, Yi Y, Song Y, Zhang W. Gut microbiota and radiation-induced injury: mechanistic insights and microbial therapies. Gut Microbes. 2025 Dec;17(1):2528429. doi: 10.1080/19490976.2025.2528429. Epub 2025 Jul 6.
Ma CY, Zhao J, Xu XT, He XL, Qin SB, Zhou JY. Predictive biomarkers in the gut microbiome and metabolome for severe acute radiation enteritis in cervical cancer radiotherapy. Discov Oncol. 2025 Jul 1;16(1):1220. doi: 10.1007/s12672-025-03077-y.
Other Identifiers
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PIFIISC25/52
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CIGC'25/26
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2025-436-1
Identifier Type: -
Identifier Source: org_study_id