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New treatment option for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Official title Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT06706544
What this study is testing
What is Ozone therapy?
Ozone therapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for chemotherapy induced peripheral neuropathy (cipn).
Also referred to as Ozone treatment, O3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this phase II/III randomized clinical trial is to evaluate the effect of adding rectal ozone therapy to the usual management of patients with paresthesia (numbness and/or tingling) due to chemotherapy-induced peripheral neuropathy (CIPN). Ozone treatment consists of the rectal insufflation of 180 - 300 milliliters of an ozone/oxygen gas mixture.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 4\. Without neurotoxic chemotherapy \> = 3 months.
- 5\. Cancer disease is stable or in remission.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 8\. To sign and date the study-specific informed consent
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Las Palmas, Las Palmas, Spain
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Las Palmas, Las Palmas, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.