Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy

Summary

The goal of this phase II/III randomized clinical trial is to evaluate the effect of adding rectal ozone therapy to the usual management of patients with paresthesia (numbness and/or tingling) due to chemotherapy-induced peripheral neuropathy (CIPN). Ozone treatment consists of the rectal insufflation of 180 - 300 milliliters of an ozone/oxygen gas mixture.

The main questions to answer are:

1. Can ozone therapy improve patients' self-perceived level of numbness and tingling?
2. Can ozone therapy improve patients' self-perceived health-related quality of life (HRQoL)?

In 42 patients with chronic numbness and tingling secondary to chemotherapy, the researchers will compare:

* the addition of rectal ozone insufflations
* versus the addition of rectal oxygen insufflations (placebo). Participants will receive 40 rectal gas (ozone versus oxygen) insufflations in 16 weeks and will continue other symptomatic or cancer treatments prescribed by their oncologists.

Before treatment, after treatment, and 12 weeks after treatment, they will be evaluated:

* Several questionnaires about neuropathy, quality of life, and anxiety and depression.
* Biochemical parameters of oxidative stress and inflammation
* Hyperspectral images of hands and feet
* Toxicity of procedure.

Conditions

• Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Paresthesia
• Numbness
• Tingling

Interventions

DRUG

Ozone therapy

Usual treatment (by their oncologist or hematologist) + Ozone therapy by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.

DRUG

Oxygen (placebo)

Usual treatment (by their oncologist or hematologist) + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.

Sponsors & Collaborators

• Council of Gran Canaria

  collaborator OTHER

• CIBER (Infectious diseases)

  collaborator UNKNOWN

• Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias

  collaborator OTHER

• Complejo Hospitalario Universitario Insular Materno Infantil

  collaborator OTHER

• Servicio de Evaluacion del Servicio Canario de Salud.

  collaborator UNKNOWN

• Institute for Applied Microelectronics, University of Las Palmas de Gran Canaria, Spain

  collaborator UNKNOWN

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Bernardino Clavo, MD, PhD

  lead OTHER

Principal Investigators

• Bernardino Clavo, MD, PhD · Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

• Francisco Rodríguez-Esparragón, BSc, PhD · Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

• Himar Fabelo, BSc, PhD · Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

• Gustavo M Callicó, Prof, PhD · Institute for Applied Microelectronics, University of Las Palmas de Gran Canaria, Spain

• Francisco Rodríguez-Esparragón, BSc, PhD · Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

• Bernardino Clavo, MD, PhD · Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-07

Primary Completion

2029-12-31

Completion

2030-03-31

Countries

• Spain

Study Locations