Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-30 @ 8:36 AM
Study NCT ID:
NCT06816095
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Sponsor:
Bernardino Clavo, MD, PhD
Organization:
Study Overview
Official Title:
Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OzoGynEpigen
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.
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.
Detailed Description:
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:
In patients with gynecological tumors treated by radiotherapy/chemotherapy, To evaluate
* among patients with or without chronic pelvic pain induced by treatment.
* before and after ozone treatment in those patients treated because of pelvic pain induced by radiotherapy/chemotherapy.
The potential differences in:
1. Gene expression.
2. Biological age based on epigenetic clocks:
Secondary Objectives:
Evaluate in those patients the potential relationship between gene expression and epigenetic clocks with:
1. Grade of toxicity
2. Pain score
3. Health-related quality of life,
4. Biochemical markers of oxidative stress and inflammation.
Trial Design:
This observational and prospective study will analyze data from two groups of patients with gynecological tumors treated with radiotherapy/chemotherapy:
* A group of patients with chronic pelvic pain secondary to radiotherapy-chemotherapy, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment.
* A group of patients without secondary chronic pelvic pain.
Trial Population:
Adult women (≥ 18 years old) with gynecological tumors treated with radiotherapy-chemotherapy. They will be analyzed into two different groups of patients:
* A group of patients with chronic pelvic pain secondary to radiotherapy-chemotherapy, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment.
* A group of patients without secondary chronic pelvic pain.
Intervention. No intervention. The management of patients will be the standard of care in our hospital.
Study Duration:
The primary completion date is planned for 14/February/2027. The study completion date is planned for 14/August/2027
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:
In patients with gynecological tumors treated by radiotherapy/chemotherapy, To evaluate
* among patients with or without chronic pelvic pain induced by treatment.
* before and after ozone treatment in those patients treated because of pelvic pain induced by radiotherapy/chemotherapy.
The potential differences in:
1. Gene expression.
2. Biological age based on epigenetic clocks:
Secondary Objectives:
Evaluate in those patients the potential relationship between gene expression and epigenetic clocks with:
1. Grade of toxicity
2. Pain score
3. Health-related quality of life,
4. Biochemical markers of oxidative stress and inflammation.
Trial Design:
This observational and prospective study will analyze data from two groups of patients with gynecological tumors treated with radiotherapy/chemotherapy:
* A group of patients with chronic pelvic pain secondary to radiotherapy-chemotherapy, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment.
* A group of patients without secondary chronic pelvic pain.
Trial Population:
Adult women (≥ 18 years old) with gynecological tumors treated with radiotherapy-chemotherapy. They will be analyzed into two different groups of patients:
* A group of patients with chronic pelvic pain secondary to radiotherapy-chemotherapy, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment.
* A group of patients without secondary chronic pelvic pain.
Intervention. No intervention. The management of patients will be the standard of care in our hospital.
Study Duration:
The primary completion date is planned for 14/February/2027. The study completion date is planned for 14/August/2027
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: