Evaluating Ozone Therapy Added to Standard Care for Pain from Chemotherapy-induced Peripheral Neuropathy in Adults

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)