Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Differences in gene expression among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy.
研究概览
简要总结
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.
详细描述
While survival rates of gynecological cancers have improved, many women experience chronic pelvic pain as a consequence of cancer treatment, particularly radiotherapy and chemotherapy. This persistent pain often has neuropathic characteristics, and it can be challenging to manage, negatively impacting physical and emotional well-being and quality of life.
Conventional pain management strategies for these patients often provide limited relief. In our experience, ozone therapy has emerged as a promising option for managing chronic pain in various conditions, including side effects of cancer treatment.
While the clinical benefits of ozone therapy have been observed in preliminary studies, the underlying molecular mechanisms underlying its analgesic effect remain largely unknown. Understanding how ozone therapy influences gene expression and epigenetic modifications could facilitate the identification of genes involved in the differential response to ozone therapy and a potential way for personalized strategies for pain treatment.
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.
Primary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Treated patients, with chronic pelvic pain
Patients with gynecological tumors, treated with radiotherapy/chemotherapy, with chronic pelvic pain, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment.
Treated patients, without secondary pain
Patients with gynecological tumors, treated with radiotherapy/chemotherapy, without chronic pelvic pain.
结局指标
主要结局
Differences in gene expression among patients with or without chronic pelvic pain induced by radiotherapy/chemotherapy.
时间窗: At 0 week
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.
时间窗: At 16 weeks
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
时间窗: At 0 week.
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
时间窗: At 16 weeks.
Changes (from baseline) in the biological age based on epigenetic clocks, after ozone treatment
次要结局
- Differences in "Quality of Life" (using the EQ-5D-5L questionnaire) self-perceived by patients among patients with or without chronic pain induced by radiotherapy/chemotherapy.(At 0 week.)
- Changes (from baseline) in "Quality of Life" (using the EQ-5D-5L questionnaire) self-perceived by patients, after ozone treatment.(At 16 weeks.)
- Differences in biochemical parameters of inflammation among patients with or without chronic pain induced by radiotherapy/chemotherapy.(At 0 week.)
- Differences in pain score according to the visual analog scale (VAS) among patients with or without chronic pain induced by radiotherapy/chemotherapy(At 0 week.)
- 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.(At 16 weeks.)
- 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(At 0 week.)
- Change (from baseline) in pain score according to the visual analog scale (VAS), after ozone treatment.(At 16 weeks.)
- Differences in biochemical parameters of oxidative stress among patients with or without chronic pain induced by radiotherapy/chemotherapy.(At 0 week.)
- Changes (from baseline) in biochemical parameters of oxidative stress, after ozone treatment.(At 16 weeks.)
- Changes (from baseline) in biochemical parameters of inflammation, after ozone treatment.(At 16 weeks.)
研究者
Bernardino Clavo, MD, PhD
Head of the Research Unit
Hospital Universitario de Gran Canaria Doctor Negrín