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

Launched by BERNARDINO CLAVO, MD, PHD · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding ozone therapy can help patients who experience numbness and tingling in their hands and feet due to chemotherapy. The trial involves 42 adults who have been dealing with these symptoms for at least three months. Participants will receive either ozone or oxygen gas through a rectal treatment 40 times over 16 weeks, while still continuing their usual cancer care.

To be eligible for this trial, participants must be at least 18 years old and have a stable or in-remission cancer diagnosis, along with a specific level of numbness and tingling. Researchers will assess how the treatments affect the patients' feelings about their symptoms and overall quality of life, using questionnaires and other tests before, after, and 12 weeks after the treatment. This trial is currently recruiting participants, and it's important to note that certain health conditions and circumstances may prevent someone from joining.

Gender

ALL

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