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

Launched by BERNARDINO CLAVO, MD, PHD · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial, called OzoParQT, is looking at how the gut microbiome, which is the collection of bacteria in our intestines, might be connected to chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a painful condition that can cause numbness, tingling, and other uncomfortable feelings in the hands and feet, often as a side effect of chemotherapy. The study is particularly interested in whether patients receiving a new treatment called rectal ozone therapy experience different changes in their gut bacteria compared to those receiving a placebo (a treatment without active ingredients).

To be eligible for this trial, participants must be adults over 18 who have experienced symptoms of CIPN for at least three months and have a stable cancer diagnosis. They should also be willing to provide stool samples to help researchers analyze their gut bacteria. Over 16 weeks, all participants will receive standard care for their CIPN symptoms along with either ozone therapy or placebo. This trial will help us understand if the gut microbiome plays a role in how well patients respond to treatments for CIPN, which could lead to better management options in the future.

Gender

ALL

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