Ozone therapy for chronic pain management in cancer patients

Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025. (EPOOzo)

This study is testing if ozone therapy can help improve the quality of life for cancer patients dealing with chronic pain and other tough symptoms.

Quick facts

• Study type: Observational
• Enrollment: 105 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dr. Negrin University Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Las Palmas, Las Palmas)
• Trial ID: NCT05417737 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the impact of ozone therapy on the health-related quality of life (HRQoL) of patients with refractory symptoms referred to the Chronic Pain Unit at Dr. Negrín University Hospital. The study will assess various parameters, including anxiety, depression, pain levels, and toxicity grades, before and after treatment. Patients will complete standardized questionnaires to measure these outcomes over the course of the study, which runs from June 2022 to December 2025.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with refractory symptoms from cancer treatments who have not benefited from standard therapies.

Not a fit: Patients with uncontrolled cancer disease or those unable to comply with study requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic pain and treatment-related side effects.

How similar studies have performed: While ozone therapy is a novel approach in this context, similar studies have shown promising results in managing chronic pain and treatment-related symptoms.

Eligibility criteria

Inclusion Criteria:

1. Adults \> = 18 years old.
2. Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín for symptomatic/palliative treatment with ozone therapy because conventional treatment does not exist, it has been unsuccessful, or it is associated with high risk or high 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 have signed and dated the informed consent for the compassionated ozone treatment and the specific informed consent for this study

Exclusion Criteria:

1. Age \< 18 years old.
2. Psychiatric illness or social situations that would limit compliance with study requirements.
3. Those who are incapable to fill in the scales used to measure variables.
4. Hemodynamically or clinically unstable patients or uncontrolled severe illness.
5. Uncontrolled cancer disease requiring chemotherapy treatment.
6. Life expectancy \< 6 months
7. Contraindication or disability or to attend scheduled treatments.
8. Known allergy to ozone.
9. Pregnancy at the time of enrollment (for systemic ozone therapy). 10 Hemochromatosis (for systemic ozone therapy).

11\. Known significant glucose-6-phosphate dehydrogenase deficiency (favism, acute hemolytic anemia) (for systemic ozone therapy).

12\. Patients who do not meet all the inclusion criteria

Where this trial is running

Las Palmas, Las Palmas

• Dr. Negrín University Hospital — Las Palmas, Las Palmas, Spain (Recruiting)

Study contacts

• Principal investigator: Bernardino Clavo, MD, PhyD — Dr. Negrín University Hospital, Las Palmas, Spain
• Study coordinator: Bernardino Clavo, MD, PhyD

Conditions Radiation Toxicity; Chemotherapeutic Toxicity; Chemotherapy-induced Peripheral Neuropathy; Delayed Wound Healing; Chronic Pain; Refractory Pain; Radiation-induced toxicity; Cancer-treatment side effects