Phase 3 Peripheral Neuropathy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who agree to take part in the related OzoParQT clinical trial and are willing to provide stool samples for gut bacteria analysis.
- Adults aged 18 or older.
- People who have previously received chemotherapy for any type of cancer.
- People who have been diagnosed with numbness or tingling caused by chemotherapy-related nerve damage, rated at a moderate-to-severe level (Grade 2 or higher on a standard medical scale) lasting for 3 months or more.
- People who have not received nerve-damaging chemotherapy for at least 3 months before joining.
- People whose cancer is currently stable or in remission.
- People with a life expectancy of at least 6 months.
- Women who could become pregnant must have a negative pregnancy test before enrolling and must agree to use appropriate contraception starting at least 14 days before the first treatment session through to 14 days after the last session.
- People who are willing to sign the informed consent forms for both related studies.
Who may not be able to join:
- People under 18 years of age.
- Women who are pregnant, breastfeeding, suspected of being pregnant, or who are of childbearing age and are not willing to use adequate contraception.
- People whose nerve symptoms are thought to be caused by diabetes-related nerve damage or nerve compression rather than chemotherapy.
- People with severe psychiatric conditions.
- People who are unable to complete quality-of-life questionnaires.
- People with significantly elevated kidney function markers in their blood (more than 5 times the upper limit of normal for creatinine) (confirm with trial site).
- People who are medically unstable or who need urgent medical treatment in the near term.
- People whose cancer is currently progressing and who need to start or continue nerve-damaging chemotherapy.
- People with a life expectancy of less than 6 months for any reason.
- People with a known allergy to ozone, a condition called G6PD deficiency, or a condition called hemochromatosis.
- People for whom rectal ozone therapy is not suitable, or who are unable to attend treatment sessions regularly.
- People who do not meet all of the inclusion criteria listed above.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bernardino Clavo, MD, PhD, Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Phone: 34928449278
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change from baseline in gut microbiome profile, at the end of ozone therapy.; Change from baseline in "numbness and tingling" self-perceived by patients at the end of ozone treatment.; Changes from baseline in the degree of neuropathy according to the QLQ-CIPN20 scale at the end of ozone treatment.; Changes from baseline in the Grade of toxicity of parestesias (numbness, tingling) according to the CTCAE v.5.0. scale at the end of ozone treatment.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.