Status:
RECRUITING
Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
Lead Sponsor:
Bernardino Clavo, MD, PhD
Collaborating Sponsors:
Servicio Canario de Salud
Instituto de Salud Carlos III
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Pain, Neuropathic
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
Brief 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-ind...
Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) decreases the quality of life of patients and can lead to a decrease and/or interruption of the chemotherapy treatment-limiting its effectiveness. The...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
- Patients who do not meet all the inclusion criteria.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04299893
Start Date
November 30 2020
End Date
December 31 2027
Last Update
September 2 2025
Active Locations (2)
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1
Complejo Hospitalario Materno Insular
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
2
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35019