Clinical trial · Observational
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
Gynecological cancers, including those affecting the ovaries, uterus, and cervix, represent a significant health burden for women. While survival rates have improved, many women experience chronic pelvic pain secondary to cancer treatment, especially radiotherapy and chemotherapy. This treatment-induced pelvic pain can be of difficult management and significantly affects patients' quality of life. In our experience, ozone therapy has emerged as a promising complementary treatment for pain relief in patients with chronic diseases, including side effects of cancer treatment. However, the genetic and epigenetic mechanisms influencing its effectiveness have not yet been thoroughly studied. The aim of this prospective study is to analyze how ozone therapy modulates the expression of certain genes and its impact on epigenetic clocks, which could help predict pain response.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pelvic Pain Syndrome (CPPS) | — | UNRESOLVED | — |
| Gynecological Cancers | — | UNRESOLVED | — |
| Radiation-Induced Disorder | — | UNRESOLVED | — |
| Radiotherapy Side Effects | — | UNRESOLVED | — |
| Side Effect of Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Treated patients, without secondary pain
- description
- Patients with gynecological tumors, treated with radiotherapy/chemotherapy, without chronic pelvic pain.
- label
- Treated patients, with chronic pelvic pain
- description
- Patients with gynecological tumors, treated with radiotherapy/chemotherapy, with chronic pelvic pain, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment.
Primary outcomes (4)
- measure
- Differences in gene expression among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy.
- timeFrame
- At 0 week
- description
- Differences (among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy) in gene expression profile.
- measure
- Changes (from baseline) in gene expression at the end of ozone treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women (\>=18 years old) with gynecological tumors treated with radiotherapy-chemotherapy. * Cancer disease is stable or in remission. * Life expectancy \> = 6 months. * Patients included in the group of patients with pelvic pain must have a clinical, radiological, endoscopic, or histopathological diagnosis that their pain is not secondary to the oncological process. * Patients included in the group of patients with pelvic pain must have pain for \>= 3 months duration, with an intensity \>= 3 on the Visual Analog Scale (VAS), or classified as toxicity \>= Grade-2 of the CTCAE v.5.0 of the National Cancer Institute of the USA. * Signed and dated informed consent specific to this study. Exclusion Criteria: * Age \< 18 years old. * Severe psychiatric disorders. * Inability to complete the quality of life questionnaires. * Active neoplasia requiring recent initiation (\< 3 months) of systemic or local treatment. * Life expectancy (for any reason) \< 6 months. * Failure to meet all inclusion criteria
References
Publications (15)
- BACKGROUNDTricarico G, Travagli V. The Relationship between Ozone and Human Blood in the Course of a Well-Controlled, Mild, and Transitory Oxidative Eustress. Antioxidants (Basel). 2021 Dec 4;10(12):1946. doi: 10.3390/antiox10121946. PMID 34943049
- BACKGROUNDHidalgo-Tallon FJ, Torres-Morera LM, Baeza-Noci J, Carrillo-Izquierdo MD, Pinto-Bonilla R. Updated Review on Ozone Therapy in Pain Medicine. Front Physiol. 2022 Feb 23;13:840623. doi: 10.3389/fphys.2022.840623. eCollection 2022. PMID 35283802
- BACKGROUNDGalie M, Covi V, Tabaracci G, Malatesta M. The Role of Nrf2 in the Antioxidant Cellular Response to Medical Ozone Exposure. Int J Mol Sci. 2019 Aug 17;20(16):4009. doi: 10.3390/ijms20164009. PMID 31426459
- BACKGROUNDClavo 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. PMID 26357522
- BACKGROUNDClavo B, Rodriguez-Esparragon F, Rodriguez-Abreu D, Martinez-Sanchez G, Llontop P, Aguiar-Bujanda D, Fernandez-Perez L, Santana-Rodriguez N. Modulation of Oxidative Stress by Ozone Therapy in the Prevention and Treatment of Chemotherapy-Induced Toxicity: Review and Prospects. Antioxidants (Basel). 2019 Nov 26;8(12):588. doi: 10.3390/antiox8120588. PMID 31779159
- BACKGROUNDClavo 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. PMID 33738491