Actively Recruiting

Age: 18Years +
FEMALE
ID06816095

Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy

Led by Bernardino Clavo, MD, PhD · Updated on 2025-02-12

40

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

B

Bernardino Clavo, MD, PhD

Lead Sponsor

F

Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias (FIISC)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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 more.
  • For patients with pelvic pain: diagnosis confirming pain is not due to active cancer.
  • For patients with pelvic pain: pain lasting 3 months or more with intensity ≥3 on the Visual Analog Scale or toxicity Grade ≥2 on CTCAE v.5.0.
  • Signed and dated informed consent specific to this study.
Not Eligible

You will not qualify if you...

  • Younger than 18 years old.
  • Severe psychiatric disorders.
  • Unable to complete quality of life questionnaires.
  • Active cancer requiring new treatment started less than 3 months ago.
  • Life expectancy less than 6 months.
  • Failure to meet all inclusion criteria.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Trial Site Locations

Total: 1 location

1

Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)

Las Palmas, Las Palmas, Spain, 35019

Actively Recruiting

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Research Team

B

Bernardino Clavo, MD, PhD

F

Francisco Rodríguez-Esparragón, BSc, PhD

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

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Published Research Related To This Trial

Ozone Therapy in the Management of Persistent Radiation-Induced Rectal Bleeding in Prostate Cancer Patients.

Bernardino Clavo, Norberto Santana-Rodriguez, Pedro Llontop...

https://pubmed.ncbi.nlm.nih.gov/26357522

Modulation of Oxidative Stress by Ozone Therapy in the Prevention and Treatment of Chemotherapy-Induced Toxicity: Review and Prospects.

Bernardino Clavo, Francisco Rodríguez-Esparragón, Delvys Rodríguez-Abreu...

https://pubmed.ncbi.nlm.nih.gov/31779159

Long-Term Results with Adjuvant Ozone Therapy in the Management of Chronic Pelvic Pain Secondary to Cancer Treatment.

Bernardino Clavo, Minerva Navarro, Mario Federico...

https://pubmed.ncbi.nlm.nih.gov/33738491

Ozone Therapy in Refractory Pelvic Pain Syndromes Secondary to Cancer Treatment: A New Approach Warranting Exploration.

Bernardino Clavo, Minerva Navarro, Mario Federico...

https://pubmed.ncbi.nlm.nih.gov/32379556

Long-term improvement by ozone treatment in chronic pain secondary to chemotherapy-induced peripheral neuropathy: A preliminary report.

Bernardino Clavo, Delvys Rodríguez-Abreu, Saray Galván...

https://pubmed.ncbi.nlm.nih.gov/36111149

Modulation by Ozone Therapy of Oxidative Stress in Chemotherapy-Induced Peripheral Neuropathy: The Background for a Randomized Clinical Trial.

Bernardino Clavo, Gregorio Martínez-Sánchez, Francisco Rodríguez-Esparragón...

https://pubmed.ncbi.nlm.nih.gov/33802143

Effects of Ozone Treatment on Health-Related Quality of Life and Toxicity Induced by Radiotherapy and Chemotherapy in Symptomatic Cancer Survivors.

Bernardino Clavo, Angeles Cánovas-Molina, Yolanda Ramallo-Fariña...

https://pubmed.ncbi.nlm.nih.gov/36674232