NCT05417737 Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025
| NCT ID | NCT05417737 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bernardino Clavo, MD, PhD |
| Condition | Radiation Toxicity |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 105 participants in total. It began in 2022-06-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 adjuvant palliative treatment with ozone therapy between June-2022 and December-2025
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
Contact & Investigator
Bernardino Clavo, MD, PhyD
STUDY CHAIR
Dr. Negrín University Hospital, Las Palmas, Spain
Frequently Asked Questions
Who can join the NCT05417737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation Toxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05417737 currently recruiting?
Yes, NCT05417737 is actively recruiting participants. Contact the research team at bernardinoclavo@gmail.com for enrollment information.
Where is the NCT05417737 trial being conducted?
This trial is being conducted at Las Palmas, Spain.
Who is sponsoring the NCT05417737 clinical trial?
NCT05417737 is sponsored by Bernardino Clavo, MD, PhD. The principal investigator is Bernardino Clavo, MD, PhyD at Dr. Negrín University Hospital, Las Palmas, Spain. The trial plans to enroll 105 participants.