Full Title: Effectiveness and cost-effectiveness of ozone treatment in managing patients with chemotherapy-induced paresthesias (numbness and tingling): triple-blind randomized clinical trial (OzoParQT)
Funded by: Instituto de Salud Carlos III (FIS PI23/01324)
Grant awarded: €90,000.00
Duration: 3 years (2024-2026)
Principal Investigator: Bernardino Clavo Varas, Francisco Javier Rodríguez Esparragon (Co-PI)
Associated Researchers: Miguel Ángel García Bello (SESCS)
Objectives and Methodology of the Project:
Chemotherapy-induced peripheral neuropathy (CIPN) can lead to a reduction and/or interruption of chemotherapy treatment (tt°), limiting its effectiveness, and decreasing the patients’ quality of life. Therapeutic options for CIPN are very limited in number and efficacy. Our previous work suggests the potential clinical utility of adjunctive ozone therapy in patients with CIPN.
MAIN OBJECTIVES:
- Evaluate the clinical effect and impact on health-related quality of life (HRQoL) of adding ozone to the usual treatment for patients with paresthesias (tingling and/or numbness) due to CIPN.
- Estimate the additional costs and assess the cost-effectiveness ratio.
SECONDARY OBJECTIVES: Evaluate the effect on the progression of: 3) Anxiety/depression levels, 4) Oxidative stress and inflammation parameters.
METHODOLOGY: Phase II-III clinical trial, randomized, triple-blind; 42 patients with any tumor, experiencing paresthesias (tingling, numbness) due to CIPN of grade > 2 for > 3 months. All patients will receive standard treatment plus 40 sessions of rectal ozone insufflation over 16 weeks: i) Ozone Group, increasing O3/O2 concentration from 10 to 30 µg/ml; ii) Control-Placebo Group, O3/O2 concentration = 0 µg/ml. Primary Variables: Progression of:
- Paresthesias (tingling and/or numbness);
- HRQoL questionnaires (EQ-5D-5L, QLQ-C30, and CIPN20);
- Direct costs. Assessments will be made at: 0 (baseline), 16 (end of ozone insufflation), and 28 weeks (endpoint and end of follow-up).
Contact Person: Bernardino Clavo Varas