NCT06816095 Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
| NCT ID | NCT06816095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bernardino Clavo, MD, PhD |
| Condition | Chronic Pelvic Pain Syndrome (CPPS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-02-10 with a primary completion date of 2027-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Bernardino Clavo, MD, PhD
STUDY CHAIR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain.
Frequently Asked Questions
Who can join the NCT06816095 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Chronic Pelvic Pain Syndrome (CPPS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06816095 currently recruiting?
Yes, NCT06816095 is actively recruiting participants. Contact the research team at bernardinoclavo@gmail.com for enrollment information.
Where is the NCT06816095 trial being conducted?
This trial is being conducted at Las Palmas, Spain.
Who is sponsoring the NCT06816095 clinical trial?
NCT06816095 is sponsored by Bernardino Clavo, MD, PhD. The principal investigator is Bernardino Clavo, MD, PhD at Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain.. The trial plans to enroll 40 participants.