Gut Microbiome Profiles in Patients With Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).

NCT ID
NCT06799351
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
Bernardino Clavo, MD, PhD
Conditions
Chemotherapy Induced Peripheral Neuropathy (CIPN), Numbness, Paresthesia, Tingling

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Evaluation of the Gut Microbiome Profiles in Patients With Chemotherapy-induced Peripheral Neuropathy Treated in the Randomized Clinical Trial With Ozone OzoParQT (NCT06706544).

Enrollment: 42 participants (Estimated).

What is being studied

  • Intervention: Chalcogens
  • Intervention: Elements
  • Intervention: Gases
  • Intervention: Inorganic Chemicals
  • Intervention: Oxygen
  • Drug: Oxygen (placebo)
  • Drug: Ozone therapy

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 0\. Patients who agree to participate in the randomized clinical trial OzoParQT, and who also agree to participate in this study of gut microbiota by providing stool samples. * 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 specific informed consent of both studies (OzoParQT and OzoParQTmicrob) 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Spain

  • Las Palmas, Spain: 1

Sample of listed locations

  • Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC) — Las Palmas, Las Palmas, 35019, Spain — Recruiting

Study details

Start date
February 7, 2025
Primary completion date
December 31, 2029
Completion date
March 31, 2030
First posted
January 29, 2025
Collaborators
Centers for International Business Education and Research, Council of Gran Canaria, Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Instituto de Salud Carlos III, Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06799351
Registry last updated
September 25, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06799351 on ClinicalTrials.gov

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