Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bernardino Clavo, MD, PhD
• Collaborators: Fundación DISA, Spain; Fundación Española del Dolor (FED); Instituto de Salud Carlos III; Red de Investigación en Servicios de Salud en Enfermedades Crónicas; Servicio Canario de Salud

Criteria

Inclusion Criteria:

• 1. Adults > = 18 years old.

• 2. Cancer of colon and rectum in any stage, with treatment including oxaliplatin, chemotherapy finished > = 3 months before and life expectancy > = 6 months.

• 3. Clinical diagnosis 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 inclusion of new treatments for pain and/or neuropathy for > = 1 month.

• 4. "Average pain" > = 4/10 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 the 14 days prior to the first ozone therapy session up to 14 days after the last one.

• 7. Patients who have signed and dated the study 's specific informed consent

Exclusion Criteria:

• 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. History or symptoms of 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 uncapable 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 requiring chemotherapy treatment.

• 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.