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

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

Conditions

• Chemotherapy-induced Peripheral Neuropathy
• Pain, Neuropathic
• Pain Syndrome

Interventions

DRUG

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.

DRUG

Oxygen

Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.

Sponsors & Collaborators

• Servicio Canario de Salud

  collaborator OTHER

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Red de Investigación en Servicios de Salud en Enfermedades Crónicas

  collaborator OTHER

• Fundación DISA, Spain

  collaborator UNKNOWN

• Fundación Española del Dolor (FED)

  collaborator UNKNOWN

• Bernardino Clavo, MD, PhD

  lead OTHER

Principal Investigators

• Bernardino Clavo, MD, PhD · Dr. Negrín University Hospital, Las Palmas, Spain

• Pedro G Serrano-Aguilar, MD, PhD · Servicio de Evaluación. Servicio Canario de Salud. Spain

• Delvys Rodríguez-Abreu, MD · Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas, Spain

• Gustavo M Callico, Prof, PhD · Institute for Applied Microelectronics, University of Las Palmas de G. C., Spain

• Francisco Rodríguez-Esparragón, BSc, PhD · Dr. Negrín University Hospital, Las Palmas, Spain

• Bernardino Clavo, MD, PhD · Dr. Negrín University Hospital, Las Palmas, Spain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2027-09-30

Completion

2027-12-31

Countries

• Spain

Study Locations