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| ID | Type | Description | Link |
|---|---|---|---|
| PIFIISC25/52 | Other Grant/Funding Number | FIISC (Fundación Canaria Inst. Investig. Sanitaria Canarias) | |
| CIGC'25/26 | Other Grant/Funding Number | Cabildo de Gran Canaria (CIGC) |
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| Name | Class |
|---|---|
| Hospital Universitario de Gran Canaria Doctor Negrín | OTHER |
| Complejo Hospitalario Universitario Insular Materno Infantil | OTHER |
| Fundación Canaria Instituto de Investigación Sanitaria de Canarias | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of gut microbiome profile (composition and diversity) between TPIRQT and Control groups | Gut microbiome composition and diversity (from a single sample) in control patients will be compared to the baseline profile of patients with TPIRQT. | Baseline (single time point for controls, pre-ozone for cases) |
| Change in gut microbiome profile (composition and diversity) in patients with TPIRQT after rectal ozone therapy. | Gut microbiome composition and diversity will be analyzed from stool samples using 16S ribosomal RNA gene sequencing. | Baseline (pre-ozone therapy) , 4 Months (post-ozone therapy) |
| Correlation of gut microbiome profile with grade of pelvic toxicity. | Toxicity will be assessed using: i) the CTCAE v.5.0 scale from the NCI , and ii) the EORTC QLQ-CX24 questionnaire. This will be evaluated for its relationship to microbiome data. | Baseline (for Control group); Baseline, 4 Months (for TPIRQT group). |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of gut microbiome profile with health-related quality of life (HRQoL). | HRQoL will be assessed using: i) the EQ-5D-5L questionnaire, and ii) the EORTC QLQ-C30 questionnaire. This will be evaluated for its relationship to microbiome data. | Baseline (for Control group); Baseline, 4 Months (for TPIRQT group). |
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Inclusion Criteria for all patients (Cases and Controls):
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.
Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):
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 for all patients (Cases and Controls):
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Patients with gynecological tumors treated with RT and/or CT with or without chronic pelvic toxicity (TPIRQT).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernardino Clavo, MD, PhD | Contact | 34928449278 | bernardinoclavo@gmail.com | |
| Francisco Rodríguez-Esparragón, BSc, PhD | Contact | 34928449288 | afrodesp@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bernardino Clavo, MD, PhD | Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain | Study Chair |
| Jacob Lorenzo-Morales, Prof | Instituto Universitario de Enfermedades Tropicales y Salud Publica de Canarias, Universidad La Laguna |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC) | Las Palmas de Gran Canaria | Las Palmas | 35019 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36674232 | Background | 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. | |
| 33738491 |
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Data will be available after publication, ending 36 months following article publication.
They will be available for investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
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| Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna | UNKNOWN |
| Centers for International Business Education and Research | OTHER |
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Stool and serum samples
| Correlation of gut microbiome profile with anxiety and depression levels. |
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). This will be evaluated for its relationship to microbiome data. |
| Baseline (for Control group); Baseline, 4 Months (for TPIRQT group). |
| Correlation of gut microbiome profile with biochemical markers of oxidative stress and inflammation. | Serum samples will be collected to analyze biochemical parameters of oxidative stress and inflammation and their potential relationship with gut microbiome composition. | Baseline (for Control group); Baseline, 4 Months (for TPIRQT group). |
| Francisco Rodríguez-Esparragón, BSc, PhD | Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain | Principal Investigator |
| Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias - Universidad de La Laguna | San Cristóbal de La Laguna | Tenerife | 38296 | Spain |
|
| Background |
| 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. |
| 32379556 | Background | 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. |
| 26357522 | Background | 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. |
| 23102757 | Background | 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. |
| 25955845 | Background | 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. |
| 34563216 | Background | 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. |
| 40618373 | Background | 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. |
| 40591053 | Background | 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. |
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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