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
- Chronic Pelvic Pain Syndrome (CPPS)
- Radiation-Induced Disorder
- Radiotherapy Side Effects
- Side Effect of Chemotherapy
- Gynecological Cancers
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Bernardino Clavo, MD, PhD
- Enrolment target
- 40
- Started
- 10 February 2025
- Main results due
- 14 February 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas, Las Palmas, Spain
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06816095. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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