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New treatment option for Chemotherapy-induced Peripheral Neuropathy
Official title Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
ClinicalTrials.gov ID: NCT04299893
What this study is testing
What is Ozone?
Ozone is an investigational medicine, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy.
Also referred to as 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 main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to the clinical management of patients with pain secondary to chemotherapy-induced peripheral neuropathy
- 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 to 100
You may be able to join if
- 1\. Adults \> = 18 years old.
- 2\. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy \> = 6 months.
- 3\. Clinical diagnosis of painful chemotherapy-induced peripheral neuropathy, toxicity Grade 2 or higher according to the Common Toxicity Criteria...
- 4\. "Average pain" \> = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) \> = 3 months beyond chemotherapy completion.
- 5\. Pregnant women cannot participate in the clinical trial.
You likely can't join if
- 1\. Age \< 18 years old.
- 2\. Pregnancy at the time of enrollment.
- 3\. Women with childbearing potential who are unwilling to perform a pregnancy test and/or employ adequate contraception from the 14 days prior to...
- 4\. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy.
- 5\. Psychiatric illness or social situations that would limit compliance with study requirements.
- 6\. Those who are unable to fill in the scales used to measure quality of life variables
See the full eligibility criteria
- 1\. Adults \> = 18 years old.
- 2\. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy \> = 6 months.
- 3\. Clinical diagnosis of painful chemotherapy-induced peripheral neuropathy, toxicity Grade 2 or higher according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU...
- 4\. "Average pain" \> = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) \> = 3 months beyond chemotherapy completion.
- 5\. Pregnant women cannot participate in the clinical trial.
- 6\. 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...
- 7\. Patients who have signed and dated the study 's specific informed consent
- 1\. Age \< 18 years old.
- 2\. Pregnancy at the time of enrollment.
- 3\. Women with childbearing potential who are unwilling to perform a pregnancy test and/or employ adequate contraception from the 14 days prior to the first ozone therapy session up to 14 days after the last one.
- 4\. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy.
- 5\. Psychiatric illness or social situations that would limit compliance with study requirements.
- 6\. Those who are unable to fill in the scales used to measure quality of life variables
- 7\. Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) \> 5 times the upper limit of normal
- 8\. Increased creatinine \> 3 times the upper limit of normal.
- 9\. Hemodynamically or clinically unstable patients or uncontrolled severe illness.
- 10\. Uncontrolled cancer disease.
- 11\. Leptomeningeal carcinomatosis.
- 12\. Life expectancy \< 6 months
- 13\. Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
- 14\. Known allergy to ozone.
- 15.Patients who do not meet all the inclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Las Palmas de Gran Canaria, 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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Las Palmas de Gran Canaria, Las Palmas, Spain. Enter your location above to see the nearest site and check your eligibility.
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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.