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

Study acronym: OzoParQT
StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries Show 4 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 13 of 20 entries
    • Study description expanded, about 14 words
    • Publications: details revised at 20 of 20 entries
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 15, 2025 to Feb 7, 2025
    • Collaborators: 3 to 7
    • Study title shortened, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06706544
Lead Sponsor Bernardino Clavo, MD, PhD
Collaborators: Council of Gran Canaria, Centers for International Business Education and Research, Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Complejo Hospitalario Universitario Insular Materno Infantil, Servicio Canario de Salud, University of Las Palmas de Gran Canaria, Instituto de Salud Carlos III
Conditions
(from sponsor)		 Chemotherapy Induced Peripheral Neuropathy (CIPN), Paresthesia, Numbness, Tingling
Related terms Anxiety Disorders, Depression, Hypesthesia, Paresthesia
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov