OXYGEN for Chemotherapy-induced peripheral neuropathy

Inclusion criteria

• {"criterion_text":"- 1. Adults > = 18 years old."}
• {"criterion_text":"- 2. Cancer in any stage, treated with chemotherapy, and life expectancy > 6 months."}
• {"criterion_text":"- 3. Clinical diagnosis painful chemotherapy-induced peripheral neuropathy, toxicity Grade > 2 according to the Common Toxicity Criteria for Adverse Events (CTCAE) del National Cancer Institute de EEUU, v.5.0, for > 3 months and without the inclusion of new treatments for pain and/or neuropathy for > 1 month."}
• {"criterion_text":"- 4. \"Average pain\" > 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) for > 3 months."}
• {"criterion_text":"- 5. Pregnant women can not participate in the clinical trial."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 7. Patients who have signed and dated the study ʼs specific informed consent."}

Exclusion criteria

• {"criterion_text":"- 1. Age < 18 years old."}
• {"criterion_text":"- 10. Neoplasia in progression"}
• {"criterion_text":"- 11. Leptomeningeal carcinomatosis."}
• {"criterion_text":"- 12. Life expectancy < 6 months"}
• {"criterion_text":"- 13. Contraindication or disability for rectal ozone administration or to attend scheduled treatments."}
• {"criterion_text":"- 14. Known allergy to ozone."}
• {"criterion_text":"- 15. Patients who do not meet all the inclusion criteria."}
• {"criterion_text":"- 2. Pregnancy at the time of enrollment."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 4. Clinical suspicion that peripheral neuropathy is due to compressive or diabetic neuropathy in the same area prior to receiving neurotoxic chemotherapy."}
• {"criterion_text":"- 5. Psychiatric illness or social situations that would limit compliance with study requirements."}
• {"criterion_text":"- 6. Those who are uncapable to fill in the scales used to measure quality of life variables"}
• {"criterion_text":"- 7. Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) > 5 times the upper limit of normal"}
• {"criterion_text":"- 8. Increased creatinine > 3 times the upper limit of normal."}
• {"criterion_text":"- 9. Hemodynamically or clinically unstable patients or uncontrolled severe illness."}

Primary endpoints

• {"endpoint_text":"- the “average pain” level according to the Brief Pain Inventory-Short Form (BPI-SF).","definition_or_measurement_approach":"Measured as the “average pain” score using the Brief Pain Inventory-Short Form (BPI-SF)."}
• {"endpoint_text":"- Direct hospital costs. The use of hospital resources (medication, tests, medical visits, medical supplies, etc.) and the associated cost will be collected (from the information generated in the Admission, Accounting Management and Analytical Accounting Services of our Hospital).","definition_or_measurement_approach":"Collected resource use and associated direct hospital costs from hospital administrative systems (Admission, Accounting Management and Analytical Accounting Services)."}

Secondary endpoints

• {"endpoint_text":"- 1. Quality of Life (QOL) measured by \"EQ-5D-5L\" questionnaire","definition_or_measurement_approach":"Measured using the EQ-5D-5L questionnaire."}
• {"endpoint_text":"- 2. Quality of Life (QOL) measured by \"SF-36v2, 1 week\" questionnaire.","definition_or_measurement_approach":"Measured using the SF-36v2 (1-week) questionnaire."}
• {"endpoint_text":"- 3. Biochemical parameters of oxidative stresss","definition_or_measurement_approach":"Changes in biochemical markers of oxidative stress measured in laboratory assays (specific assays not detailed in CTIS record)."}
• {"endpoint_text":"- 4. Biochemical parameters of inflammation","definition_or_measurement_approach":"Changes in biochemical markers of inflammation measured in laboratory assays (specific assays not detailed)."}
• {"endpoint_text":"- 5. Hyperspectral image of painful area","definition_or_measurement_approach":"Hyperspectral imaging of the painful area (diagnostic/predictive value to be assessed)."}
• {"endpoint_text":"- 6. Levels of anxiety and depression according to the Hamilton scale","definition_or_measurement_approach":"Measured using the Hamilton scale for anxiety and depression."}
• {"endpoint_text":"- 7. Nerve conduction studies in the painful area","definition_or_measurement_approach":"Nerve conduction studies performed in the affected area to assess changes."}
• {"endpoint_text":"- 8. Toxicity of rectal ozone therapy in these patients.","definition_or_measurement_approach":"Assessment and reporting of adverse events and toxicities related to rectal ozone therapy."}
• {"endpoint_text":"- 9. Acceptability of a shared decision making (SDM) tool among professionals and patients","definition_or_measurement_approach":"Assessment of acceptability of the SDM tool among professionals and patients (methods not specified in CTIS record)."}

Spain

Earliest CTIS Part Ii Submission Date

18-09-2024

Latest Decision Or Authorization Date

26-09-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

42

Primary sponsor

Full Name

Dr. Bernardino Clavo Varas

Organisation Type

Health care

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"ES","full_name":"S.E. CARBUROS METÁLICOS, S.A.","duties_or_roles":"Manufacturer/supplier of the medicinal oxygen product used as IMP","organisation_type":""}