Actively Recruiting
Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
Led by Bernardino Clavo, MD, PhD · Updated on 2025-09-02
42
Participants Needed
2
Research Sites
369 weeks
Total Duration
On this page
Sponsors
B
Bernardino Clavo, MD, PhD
Lead Sponsor
S
Servicio Canario de Salud
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Any type and stage of cancer treated with any chemotherapy
- Life expectancy of at least 6 months
- Clinical diagnosis of painful chemotherapy-induced peripheral neuropathy grade 2 or higher lasting 3 months or more
- Average pain score of 3 or higher on the Brief Pain Inventory-Short Form for at least 3 months after chemotherapy
- Negative pregnancy test before enrollment for women of childbearing potential
- Agreement to use effective contraception from 14 days before first ozone therapy to 14 days after last session
- Signed informed consent form
You will not qualify if you...
- Under 18 years old
- Pregnant at enrollment
- Women of childbearing potential unwilling to have pregnancy test or use contraception as required
- Suspected peripheral neuropathy from causes other than chemotherapy
- Psychiatric or social conditions limiting study compliance
- Unable to complete quality of life questionnaires
- Liver enzymes (AST or ALT) over 5 times normal
- Creatinine over 3 times normal
- Clinically unstable or uncontrolled severe illness
- Uncontrolled cancer
- Leptomeningeal carcinomatosis
- Life expectancy less than 6 months
- Contraindications or inability to receive rectal ozone or attend treatments
- Known allergy to ozone
- Failure to meet all inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Complejo Hospitalario Materno Insular
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Actively Recruiting
2
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
Actively Recruiting
Research Team
B
Bernardino Clavo, MD, PhD
CONTACT
D
Delvys Rodríguez-Abreu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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