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Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy
Sponsor: Bernardino Clavo, MD, PhD
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.
Official title: Effectiveness and Cost-effectiveness of Ozone Treatment in Patients With Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (OzoParQT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2025-02-07
Completion Date
2030-03-31
Last Updated
2025-02-11
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Dr. Negrín University Hospital
Las Palmas, Las Palmas, Spain