RecruitingNCT06816095

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

Sponsor

Bernardino Clavo, MD, PhD

Enrollment

40 participants

Start Date

Feb 10, 2025

Study Type

OBSERVATIONAL

Conditions

Radiation-Induced Disorder Gynecological Cancers Chronic Pelvic Pain Syndrome (CPPS)Radiotherapy Side Effects Side Effect of Chemotherapy

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: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria5

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.

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