Ozone therapy for refractory pain and quality of life in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study of adults referred to the Chronic Pain Unit at Dr. Negrín University Hospital for symptomatic/palliative ozone therapy between 2026 and 2029. The aim is to see if adding ozone therapy to current care can improve health-related quality of life and alleviate symptoms such as pain, neuropathy, fatigue, and toxicity from cancer treatments. The study will use non-invasive tools to monitor microcirculation, neuropathy, autonomic function, oxidative stress, inflammatory markers, and gut microbiota where applicable. Assessments occur at baseline, at the end of ozone treatment, and at follow-up time points to observe changes from baseline. This analysis will be contextualized within cases with treatment failure, high morbidity, or where standard options are limited or risky.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Adults ≥ 18 years old.
* 2\. Patients referred to the Chronic Pain Unit of the Dr. Negrín University Hospital for symptomatic/palliative treatment with ozone therapy because conventional treatment does not exist, has failed, has offered insufficient results, or is associated with high risk/morbidity.
* 3\. After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.
* 4\. Patients have no contraindications for ozone treatment.
* 5\. Patients must sign the specific Informed Consent for this study and for the ozone treatment.

Exclusion Criteria:

* 1\. Age \< 18 years old.
* 2\. Psychiatric illness or social situations that would limit compliance with study requirements.

Contraindication or disability to attend scheduled treatments.

* 3\. Contraindication or disability to attend scheduled treatments.
* 4\. Uncontrolled clinical conditions (e.g., severe heart failure, massive hemorrhage, status epilepticus).
* 5\. Life expectancy \< 6 months.
* 6\. Known allergy to ozone.
* 7\. Hemochromatosis (for systemic ozone treatment).
* 8\. Pregnancy (for systemic ozone treatment).
* 9\. Significant Glucose-6-Phosphate Dehydrogenase deficiency (Favism) (for systemic ozone treatment).
* 10\. Patients who do not meet the inclusion criteria.

Where it's running

• Dr. Negrín University Hospital
  Las Palmas de Gran Canaria, Las Palmas, Spain Recruiting

Study contacts

• Principal investigator: Francisco Rodríguez-Esparragón, BSc, PhyD — Dr. Negrín University Hospital, Las Palmas, Spain
• Study coordinator: Bernardino Clavo, MD, PhD.
• Email: bernardinoclavo@gmail.com
• Phone: +34 928449278

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.