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

Study acronym: OzoGynEpigen
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoints: details revised at 2 of 4 entries Show 4 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 8 of 10 entries
    • Study description expanded, about 12 words
    • Publications: details revised at 15 of 15 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  3. Start date: Feb 15, 2025 to Feb 10, 2025
    • Secondary endpoints revised (10)
    • Study description expanded, about 2 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06816095
Lead Sponsor Bernardino Clavo, MD, PhD
Collaborators: Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Fundación DISA, Canary Islands, Spain, Council of Gran Canaria
Conditions
(from sponsor)		 Chronic Pelvic Pain Syndrome (CPPS), Radiation-Induced Disorder, Radiotherapy Side Effects, Side Effect of Chemotherapy, Gynecological Cancers
Related terms Abnormalities, Radiation-Induced
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov