Ozone therapy for numbness and tingling from chemotherapy

Effectiveness and Cost-effectiveness of Ozone Treatment in Patients With Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (OzoParQT)

This study is testing if ozone therapy can help reduce numbness and tingling in cancer patients who have nerve damage from chemotherapy.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dr. Negrin University Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Las Palmas, Las Palmas)
• Trial ID: NCT06706544 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of rectal ozone therapy in improving symptoms of numbness and tingling caused by chemotherapy-induced peripheral neuropathy (CIPN). It involves a randomized comparison between ozone and placebo (oxygen) treatments over 16 weeks, with a focus on patients' self-perceived levels of paresthesia and health-related quality of life. The study aims to provide insights into the potential benefits of ozone therapy as an adjunct treatment for CIPN, which currently has limited therapeutic options.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who have experienced moderate to severe paresthesia due to chemotherapy for at least three months.

Not a fit: Patients who are under 18, pregnant, or have active neurotoxic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of numbness and tingling in patients suffering from CIPN, enhancing their quality of life.

How similar studies have performed: While ozone therapy is a novel approach in this context, previous studies have suggested potential benefits, though this specific application remains largely untested.

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

Where this trial is running

Las Palmas, Las Palmas

• Dr. Negrín University Hospital — Las Palmas, Las Palmas, Spain (RECRUITING)

Study contacts

• Principal investigator: Himar Fabelo, BSc, PhD — Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
• Study coordinator: Bernardino Clavo, MD, PhD

Conditions: Chemotherapy Induced Peripheral Neuropathy, Paresthesia, Numbness, Tingling, Chemotherapy induced peripheral neuropathy, paresthesia, numbness and tingling, side effect of cancer treatment