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Ozone treatment in patients with numbness and/or tingling secondary to chemotherapy. Randomized clinical trial.
EU CTIS ID: 2024-517196-20-00
What this study is testing
To evaluate the effect of adding ozone to the usual management of patients with paresthesia (numbness and/or tingling) due to chemotherapy-induced peripheral neuropathy (CIPN), Grade 2 (moderate symptoms and/or limitation in instrumental activities of daily living) or higher, on: 1) patients' self-perceived level of paresthesia 2) patients' self-perceived health-related quality of life (HRQoL).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults > = 18 years old.
- Previous treatment with any chemotherapy because of any tumor.
- 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.
- Without neurotoxic chemotherapy > = 3 months.
- Cancer disease stable or in remission.
- Life expectancy > = 6 months.
You likely can't join if
- Age < 18 years.
- Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.
- Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.
- Not meeting each and every one of the inclusion criteria.
- A woman who is lactating, pregnant, suspected of being pregnant, or who is of childbearing age and does not use adequate contraceptive methods.
- Suspected symptoms are due to diabetic or compressive neuropathy.
See the full eligibility criteria
- Adults > = 18 years old.
- Previous treatment with any chemotherapy because of any tumor.
- 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.
- Without neurotoxic chemotherapy > = 3 months.
- Cancer disease stable or in remission.
- Life expectancy > = 6 months.
- 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 the 14 days prior to the first ozone therapy session up to 14 days after the last one.
- To sign and date the study specific informed consent
- Age < 18 years.
- Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.
- Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.
- Not meeting each and every one of the inclusion criteria.
- A woman who is lactating, pregnant, suspected of being pregnant, or who is of childbearing age and does not use adequate contraceptive methods.
- Suspected symptoms are due to diabetic or compressive neuropathy.
- Severe psychiatric disorders.
- Inability to complete the quality of life questionnaires.
- Elevation above 5 times the maximum limit of normal creatinine.
- Patient who is hemodynamic or clinically unstable, or who requires urgent or short-term interventional measures.
- Neoplasia in progression requiring recent initiation of systemic treatment, or maintenance with neurotoxic chemotherapy.
- Life expectancy (for any reason) < 6 months.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.