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.
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.
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.
Adult women (≥18 years) with gynecological tumors treated with radiotherapy-chemotherapy.
Case-control
Prospective
Not listed
Differences in gene expression among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy.
Differences (among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy) in gene expression profile.
Changes (from baseline) in gene expression at the end of ozone treatment.
Changes (from baseline) in gene expression profile, after ozone treatment.
Differences in biological age based on epigenetic clocks among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy
Differences (among patients with or without chronic pain induced by radiotherapy/chemotherapy) in the biological age based on epigenetic clocks.
Changes (from baseline) in the biological age based on epigenetic clocks, after ozone treatment
Changes (from baseline) in the biological age based on epigenetic clocks, after ozone treatment
Differences in the grade of toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 scale among patients with or without chronic pain induced by radiotherapy/chemotherapy
Differences (among patients with or without chronic pain induced by radiotherapy/chemotherapy) in the grade of toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 scale (from the National Cancer Institute of EEUU). Range from: Grade = (asymptomatic or mild symptoms) to Grade 3 (severe symptoms, limiting self-care activities in daily life).
Changes (from baseline) in the grade of toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 scale, after ozone treatment.
Changes (from baseline) in the grade of toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 scale (from the National Cancer Institute of EEUU). Range from: Grade = (asymptomatic or mild symptoms) to Grade 3 (severe symptoms, limiting self-care activities in daily life).
Differences in pain score according to the visual analog scale (VAS) among patients with or without chronic pain induced by radiotherapy/chemotherapy
Self-reported evaluation of the severity of pain according to the VAS, scored from 0 ("No pain") to 10 ("Pain as bad as you can imagine").
Change (from baseline) in pain score according to the visual analog scale (VAS), after ozone treatment.
Self-reported evaluation of the severity of pain according to the VAS, scored from 0 ("No pain") to 10 ("Pain as bad as you can imagine").
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Bernardino Clavo, MD, PhD
Lead sponsor
Hospital Universitario de Gran Canaria Doctor Negrín
Sponsor institution
Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Collaborator
Fundación DISA, Canary Islands, Spain
Collaborator
Council of Gran Canaria
Collaborator
