NCT06706544 Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy
| NCT ID | NCT06706544 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Bernardino Clavo, MD, PhD |
| Condition | Chemotherapy Induced Peripheral Neuropathy (CIPN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2025-02-07 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 1\. Adults \> = 18 years old. * 2\. Previous treatment with any chemotherapy because of any tumor. * 3\. Clinical diagnosis of paresthesia (numbness, tingling) secondary to CIPN, with toxicity Grade \> = 2 (according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0) for \> = 3 months. * 4\. Without neurotoxic chemotherapy \> = 3 months. * 5\. Cancer disease is stable or in remission. * 6\. Life expectancy \> = 6 months. * 7\. Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit and accept the use of appropriate contraceptive methods at least from 14 days before the first ozone therapy session up to 14 days after the last one. * 8\. To sign and date the study-specific informed consent Exclusion Criteria: * 1\. Age \< 18 years. * 2\. A woman who is lactating, pregnant, suspected of being pregnant, or a woman of childbearing potential who does not use adequate contraceptive methods. * 3\. Suspected symptoms are due to diabetic or compressive neuropathy. * 4\. Severe psychiatric disorders. * 5\. Inability to complete the quality of life questionnaires. * 6\. Elevation above 5 times the maximum limit of normal creatinine. * 7\. Patient who is hemodynamic or clinically unstable or who requires urgent or short-term interventional measures. * 8\. Neoplasia in progression requiring recent initiation of systemic treatment or maintenance with neurotoxic chemotherapy. * 9\. Life expectancy (for any reason) \< 6 months. * 10\. Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis. * 11\. Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment. * 12\. Not meeting each and every one of the inclusion criteria
Contact & Investigator
Bernardino Clavo, MD, PhD
STUDY CHAIR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Frequently Asked Questions
Who can join the NCT06706544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy Induced Peripheral Neuropathy (CIPN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06706544 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06706544 currently recruiting?
Yes, NCT06706544 is actively recruiting participants. Contact the research team at bernardinoclavo@gmail.com for enrollment information.
Where is the NCT06706544 trial being conducted?
This trial is being conducted at Las Palmas, Spain.
Who is sponsoring the NCT06706544 clinical trial?
NCT06706544 is sponsored by Bernardino Clavo, MD, PhD. The principal investigator is Bernardino Clavo, MD, PhD at Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain. The trial plans to enroll 42 participants.