Actively Recruiting
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Led by Bernardino Clavo, MD, PhD · Updated on 2025-02-12
40
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
B
Bernardino Clavo, MD, PhD
Lead Sponsor
F
Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women (≥18 years old) with gynecological tumors treated with radiotherapy-chemotherapy.
- Cancer disease is stable or in remission.
- Life expectancy of 6 months or longer.
- For patients with pelvic pain: pain is not caused by the cancer itself, confirmed by clinical, radiological, endoscopic, or histopathological diagnosis.
- For patients with pelvic pain: pain duration of 3 months or more with intensity of 3 or higher on the Visual Analog Scale or toxicity grade 2 or higher per CTCAE v5.0.
- Signed and dated informed consent specific to this study.
You will not qualify if you...
- Age under 18 years old.
- Severe psychiatric disorders.
- Inability to complete quality of life questionnaires.
- Active cancer requiring systemic or local treatment started less than 3 months ago.
- Life expectancy less than 6 months for any reason.
- Failure to meet all inclusion criteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas, Las Palmas, Spain, 35019
Actively Recruiting
Research Team
B
Bernardino Clavo, MD, PhD
CONTACT
F
Francisco Rodríguez-Esparragón, BSc, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here