Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBernardino Clavo, MD, PhD

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

40 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Bernardino Clavo, MD, PhD

Lead sponsor

Dr. Negrin University Hospital

Sponsor institution

Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias (FIISC)

Collaborator

Fundación DISA, Canary Islands, Spain

Collaborator

Council of Gran Canaria

Collaborator