Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBernardino Clavo, MD, PhD
About this trial
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
Eligibility criteria
Qualifiers
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, v.5.0, for > = 3 months and without the inclusion of new treatments for pain and/or neuropathy for > = 1 month.
4. "Average pain" > = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) > = 3 months beyond chemotherapy completion.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ozone
- Oxygen
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Bernardino Clavo, MD, PhD
Lead sponsor
Dr. Negrin University Hospital
Sponsor institution
Servicio Canario de Salud
Collaborator
Instituto de Salud Carlos III
Collaborator
Red de Investigación en Servicios de Salud en Enfermedades Crónicas
Collaborator
Fundación DISA, Spain
Collaborator
Fundación Española del Dolor (FED)
Collaborator
Source ClinicalTrials.gov