Chronic Pelvic Pain Syndrome (CPPS)Radiation-Induced DisorderRadiotherapy Side EffectsSide Effect of ChemotherapyGynecological Cancers
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Differences in gene expression among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy. — At 0 week Differences (among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy) in gene expression profile.
Changes (from baseline) in gene expression at the end of ozone treatment. — At 16 weeks Changes (from baseline) in gene expression profile, after ozone treatment.
Differences in biological age based on epigenetic clocks among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy — At 0 week. Differences (among patients with or without chronic pain induced by radiotherapy/chemotherapy) in the biological age based on epigenetic clocks.
Changes (from baseline) in the biological age based on epigenetic clocks, after ozone treatment — At 16 weeks. Changes (from baseline) in the biological age based on epigenetic clocks, after ozone treatment
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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