Status:
RECRUITING
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025
Lead Sponsor:
Bernardino Clavo, MD, PhD
Collaborating Sponsors:
Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
Servicio Canario de Salud
Conditions:
Radiation Toxicity
Chemotherapeutic Toxicity
Eligibility:
All Genders
18+ years
Brief Summary
The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms, who have been referred to the HUGCDN Chronic Pain Unit for adjuvan...
Detailed Description
Chronic Pain Unit in the absence or failure of standard treatment, or when the standard treatment is associated with high morbidity or high risk. Frequently, these patients present alterations in self...
Eligibility Criteria
Inclusion
- Adults \> = 18 years old.
- 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.
- After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.
- Patients have no contraindications for ozone treatment.
- Patients have signed and dated the informed consent for the compassionated ozone treatment and the specific informed consent for this study
Exclusion
- Age \< 18 years old.
- Psychiatric illness or social situations that would limit compliance with study requirements.
- Those who are incapable to fill in the scales used to measure variables.
- Hemodynamically or clinically unstable patients or uncontrolled severe illness.
- Uncontrolled cancer disease requiring chemotherapy treatment.
- Life expectancy \< 6 months
- Contraindication or disability or to attend scheduled treatments.
- Known allergy to ozone.
- 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
Key Trial Info
Start Date :
June 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05417737
Start Date
June 15 2022
End Date
June 30 2026
Last Update
September 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. Negrín University Hospital
Las Palmas, Las Palmas, Spain, 35019