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Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
Sponsor: Bernardino Clavo, MD, PhD
Summary
The main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to the clinical management of patients with pain secondary to chemotherapy-induced peripheral neuropathy
Official title: Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2020-11-30
Completion Date
2027-12-31
Last Updated
2025-09-02
Healthy Volunteers
No
Interventions
Ozone
Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Oxygen
Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Locations (2)
Complejo Hospitalario Materno Insular
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain