RecruitingPhase 2Phase 3NCT04299893

Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)

Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)

Sponsor

Bernardino Clavo, MD, PhD

Enrollment

42 participants

Start Date

Nov 30, 2020

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Induced Peripheral Neuropathy Pain Syndrome Pain, Neuropathic

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

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oxygen and a drug called Ozone for people with chemotherapy induced peripheral neuropathy, pain syndrome, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOzone

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.

DRUGOxygen

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

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NCT04299893

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