The Relationship between Ozone and Human Blood in the Course of a Well-Controlled, Mild, and Transitory Oxidative Eustress.
Gerardo Tricarico, Valter Travagli
https://pubmed.ncbi.nlm.nih.gov/34943049Actively Recruiting
Led by Bernardino Clavo, MD, PhD · Updated on 2025-02-12
40
Participants Needed
1
Research Sites
25 weeks
Total Duration
B
Bernardino Clavo, MD, PhD
Lead Sponsor
F
Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias (FIISC)
Collaborating Sponsor
Gynecological cancers, including ovarian, uterine, and cervical cancers, pose a significant health challenge for women. Many survivors experience chronic pelvic pain caused by treatments like radiotherapy and chemotherapy, which can be difficult to manage and can greatly reduce quality of life. Researchers are studying how ozone therapy might influence gene expression and epigenetic markers to better understand and possibly predict pain relief in these patients. This observational and prospective study involves two groups of adult women with gynecological tumors treated by radiotherapy/chemotherapy: those with chronic pelvic pain who receive compassionate or palliative ozone therapy, and those without this pain. No interventions beyond standard care are applied to the group without pain. The study aims to analyze differences between these groups at the start and after 16 weeks, focusing on gene expression and biological age assessed by epigenetic clocks. Participants will be assessed at baseline and after 16 weeks of ozone therapy if applicable. Researchers will measure gene expression, epigenetic biological age, pain levels, toxicity grades, quality of life, and biochemical markers of oxidative stress and inflammation. The study duration extends to August 2027, with comprehensive monitoring to evaluate the molecular and clinical effects of ozone therapy in managing treatment-induced chronic pelvic pain.
CONDITIONS
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants with gynecological tumors treated with radiotherapy/chemotherapy are observed to assess gene expression, biological age, pain, toxicity, quality of life, and biochemical markers.
Baseline assessment and follow-up assessment at 16 weeks
Total: 1 location
1
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas, Las Palmas, Spain, 35019
Actively Recruiting
B
Bernardino Clavo, MD, PhD
F
Francisco Rodríguez-Esparragón, BSc, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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