Study of Gut Microbiome and Rectal Ozone Therapy Effects in Adults with Chemotherapy-induced Peripheral Neuropathy

What this Trial Is About

Chemotherapy-induced peripheral neuropathy CIPN is a common and distressing side effect of chemotherapy that often leads to dose reductions or interruptions, which can lessen treatment effectiveness and lower quality of life. This research is an observational study linked to a randomized clinical trial OzoParQT that explores how the gut microbiome relates to CIPN severity and response to rectal ozone therapy in adults with various tumors experiencing CIPN symptoms for at least three months. Participants receive standard care plus 40 sessions of rectal insufflation with either an O3O2 gas mixture ozone therapy gradually increasing in concentration or oxygen alone as a placebo, over a period of 16 weeks. The study compares gut microbiome profiles and symptom changes between those who experience improvement and those who do not, as well as between the ozone and placebo groups. During the 16 weeks, participants will provide stool samples and complete questionnaires assessing neuropathy severity, quality of life, anxiety, and depression. Researchers will also measure biochemical markers of oxidative stress and inflammation. The main outcomes focus on changes in gut microbiome and neuropathy symptoms, while secondary measures include quality of life and mental health assessments. The total project is planned to last 60 months.

Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).