Effectiveness and cost-effectiveness of Ozone therapy in patients with pain secondary to chemotherapy-induced peripheral neuropathy. Randomized, triple-blind clinical trial.

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518021-16-00

Acronym

O3NPIQ

Enrollment

Registered

2024-09-26

Start date

2020-11-30

Completion date

Unknown

Last updated

2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain secondary to chemotherapy-induced peripheral neuropathy

Brief summary

the “average pain” level according to the Brief Pain Inventory-Short Form (BPI-SF)., 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).

Detailed description

1. Quality of Life (QOL) measured by "EQ-5D-5L" questionnaire, 2. Quality of Life (QOL) measured by "SF-36v2, 1 week" questionnaire., 3. Biochemical parameters of oxidative stresss, 4. Biochemical parameters of inflammation, 5. Hyperspectral image of painful area, 6. Levels of anxiety and depression according to the Hamilton scale, 7. Nerve conduction studies in the painful area, 8. Toxicity of rectal ozone therapy in these patients., 9. Acceptability of a shared decision making (SDM) tool among professionals and patients

Interventions

DRUGThe Placebo is the diatomic allotrope of oxygen (O2) (Oxígeno Medicinal Gas Carburos Metálicos

DRUG99'5%)

DRUGOxígeno Medicinal Gas Carburos Metálicos

DRUG99.5% v/v gas comprimido medicinal

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
the “average pain” level according to the Brief Pain Inventory-Short Form (BPI-SF)., 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).	—

Secondary

Measure	Time frame
1. Quality of Life (QOL) measured by "EQ-5D-5L" questionnaire, 2. Quality of Life (QOL) measured by "SF-36v2, 1 week" questionnaire., 3. Biochemical parameters of oxidative stresss, 4. Biochemical parameters of inflammation, 5. Hyperspectral image of painful area, 6. Levels of anxiety and depression according to the Hamilton scale, 7. Nerve conduction studies in the painful area, 8. Toxicity of rectal ozone therapy in these patients., 9. Acceptability of a shared decision making (SDM) tool among professionals and patients	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026