Exploring ozone therapy for chronic pelvic pain in women with gynecological cancers
Official title: Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy
Run by Hospital Universitario de Gran Canaria Doctor Negrín · NCT06816095 · Data updated 2026-11-12
This study is testing whether ozone therapy can help relieve chronic pelvic pain in women with gynecological cancers after their cancer treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Hospital Universitario de Gran Canaria Doctor Negrín Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Las Palmas, Las Palmas) |
| Status | Recruiting |
| Started | February 10, 2025 |
| Main results expected | February 14, 2027 |
| Study ends | August 14, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT06816095 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult women aged 18 and older with stable or remission gynecological tumors who experience chronic pelvic pain due to cancer treatment.
✕Probably not a fit
Patients with active neoplasia requiring recent treatment or those with severe psychiatric disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the effects of ozone therapy on chronic pelvic pain experienced by women with gynecological tumors following cancer treatments like radiotherapy and chemotherapy. It aims to analyze how ozone therapy influences gene expression and epigenetic changes, potentially leading to personalized pain management strategies. The study will evaluate patients both before and after ozone treatment to assess pain response and identify genetic factors that may affect treatment outcomes.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to managing chronic pelvic pain in cancer survivors, improving their quality of life.
How similar studies have gone: Preliminary studies have shown promise for ozone therapy in pain management, but the specific genetic and epigenetic mechanisms remain largely untested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas, Las Palmas, Spain Recruiting
Study contacts
- Principal investigator: Sara Cazorla-Rivero, BSc, PhD — Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain.
- Study coordinator: Bernardino Clavo, MD, PhD
- Email: bernardinoclavo@gmail.com
- Phone: 34928449278
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.