Effectiveness and Cost-effectiveness of Ozone Treatment for Numbness and Tingling Due to Chemotherapy-induced Peripheral Neuropathy: A Randomized, Triple-blind Clinical Trial

What this Trial Is About

Researchers are investigating the effects of adding rectal ozone therapy to the usual care for patients experiencing numbness and tingling due to chemotherapy-induced peripheral neuropathy (CIPN). This phase II/III randomized, triple-blind clinical trial aims to determine whether ozone therapy can improve patients' self-perceived numbness and tingling as well as their health-related quality of life. The study also evaluates the treatment's cost-effectiveness, sensory neuropathy progression, anxiety and depression levels, biochemical markers of oxidative stress and inflammation, hyperspectral imaging changes, and treatment toxicity. Participants will be randomly assigned to receive either ozone therapy or a placebo, both given as rectal insufflations of a gas mixture. The ozone concentration will gradually increase from 10 to 30 micrograms per milliliter in the active group, while the placebo group will receive only oxygen. Each participant will undergo 40 sessions over 16 weeks, with 2 to 3 sessions per week, alongside their usual cancer or symptom treatments. Following the treatment phase, participants will be monitored for an additional 12 weeks to assess lasting effects. Throughout the 28-week study period, participants will complete questionnaires assessing neuropathy symptoms, quality of life, and mental health. Researchers will collect biochemical samples to measure oxidative stress and inflammation, perform hyperspectral imaging of hands and feet, and monitor any treatment-related toxicity. These assessments will occur before treatment, immediately after the treatment phase, and at the end of the follow-up period to evaluate both short- and long-term outcomes.

Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy