Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)

What this Trial Is About

This trial investigates the use of ozone therapy as an addition to standard treatment for patients experiencing pain from chemotherapy-induced peripheral neuropathy (CIPN). CIPN can lower quality of life and interrupt chemotherapy, but current treatments have limited effectiveness. The study aims to assess both the clinical effect on health-related quality of life and the cost-effectiveness of this therapy, along with effects on oxidative stress, inflammation, anxiety, depression, and pain assessment methods. Participants are randomly assigned to one of two groups: one receiving usual care plus ozone therapy via rectal insufflation with ozone concentrations increasing from 10 to 30 micrograms per milliliter over 40 sessions in 16 weeks, and a control group receiving usual care plus oxygen insufflation without ozone over the same schedule. The study design is a randomized, triple-blind controlled trial including 42 patients with CIPN of grade 2 or higher lasting at least 3 months. During the study, participants undergo assessments at baseline, at the end of treatment (16 weeks), and after a 12-week follow-up (28 weeks). Evaluations include pain levels using the Brief Pain Inventory-Short Form, quality of life questionnaires (EQ-5D-5L and SF-36), biochemical markers of oxidative stress and inflammation, anxiety and depression scales, nerve conduction studies, hyperspectral imaging, and cost analysis. Safety and patient acceptability of treatment and decision-making tools are also monitored throughout the trial.

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