RecruitingPhase 2Phase 3NCT06706544

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

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)


Sponsor

Bernardino Clavo, MD, PhD

Enrollment

42 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ozone therapy can reduce numbness and tingling in the hands or feet caused by nerve damage from chemotherapy — a condition called chemotherapy-induced peripheral neuropathy (CIPN). **You may be eligible if...** - You are 18 or older - You previously received chemotherapy for any type of cancer - You have persistent numbness or tingling in hands or feet (Grade 2 or higher) that has lasted at least 3 months after finishing chemotherapy - You finished neurotoxic chemotherapy at least 3 months ago - Your cancer is currently stable or in remission - Your life expectancy is at least 6 months **You may NOT be eligible if...** - You are currently receiving neurotoxic chemotherapy - Your cancer is not stable or has progressed - You are pregnant or breastfeeding - You have conditions that make ozone therapy unsafe Talk to your doctor to see if this trial is right for you.

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 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.

DRUGOxygen (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

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NCT06706544


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