Examining gut microbiome profiles in patients with chemotherapy-induced neuropathy
Evaluation of the Gut Microbiome Profiles in Patients with Chemotherapy-induced Peripheral Neuropathy Treated in the Randomized Clinical Trial with Ozone OzoParQT (NCT06706544).
This study is trying to see if the gut bacteria of patients getting ozone therapy for chemotherapy-related nerve pain can help explain why some feel better while others don’t.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dr. Negrin University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Las Palmas, Las Palmas) |
| Trial ID | NCT06799351 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between gut microbiome composition and the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing rectal ozone therapy. It aims to determine if gut microbiome profiles differ between patients who experience symptomatic improvement and those who do not, as well as between those receiving ozone therapy and a placebo. The study also evaluates the impact of gut microbiome on health-related quality of life, anxiety, depression, and biochemical markers of oxidative stress and inflammation. Participants will provide stool samples to analyze their microbiome profiles throughout the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a clinical diagnosis of CIPN and a toxicity grade of 2 or higher, who have previously received chemotherapy.
Not a fit: Patients with neurotoxic chemotherapy within the last three months or those whose cancer is not stable or in remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for chemotherapy-induced peripheral neuropathy, enhancing patients' quality of life.
How similar studies have performed: While the approach of examining gut microbiome in relation to CIPN is emerging, similar studies exploring the gut microbiome's role in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Las Palmas, Las Palmas
- Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC) — Las Palmas, Las Palmas, Spain (Recruiting)
Study contacts
- Principal investigator: Jacob Lorenzo-Morales, Prof — Instituto Universitario de Enfermedades Tropicales y Salud Publica de Canarias - Universidad de La Laguna (IUETSPC-ULL)
- Study coordinator: Bernardino Clavo, MD, PhD
- Email: bernardinoclavo@gmail.com
- Phone: 34928449278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.