Effectiveness and cost-effectiveness of ozone in the management of patients with chemotherapy-induced peripheral neuropathy pain: randomized, triple-blind clinical trial.

Full Title: Effectiveness and cost-effectiveness of ozone in the management of patients with chemotherapy-induced peripheral neuropathy pain: randomized, triple-blind clinical trial.

Funded by: Instituto de Salud Carlos III (FIS PI19/00458)

Grant awarded: €56,265.00

Duration: 3 years (01/01/2020-31/12/2022)

Principal Investigators: Bernardino Clavo Varas, Delvys Rodríguez Abreu

Collaborating Researchers: Miguel Ángel Carames Álvarez, Francisco Javier Rodríguez Esparragón, Oliver Rivero Arias, Saray Galván Ruiz, Teresa Téllez Santana

Objectives:

Chemotherapy-induced peripheral neuropathy (CIPN) reduces patients’ quality of life and may lead to a reduction and/or interruption of chemotherapy treatment, limiting its effectiveness. Therapeutic measures for CIPN are very limited in number and efficacy.

PRIMARY OBJECTIVES: 1) To evaluate the clinical effect and health-related quality of life (HRQoL) of adding ozone to the standard treatment of patients with persistent pain from CIPN. 2) To estimate the additional costs and evaluate the cost-effectiveness ratio.

SECONDARY OBJECTIVES: 3) To assess the evolution of biochemical markers of oxidative stress and chronic inflammation.

Methodology:

Phase II-III clinical trial, randomized, triple-blind; 42 patients with colon and rectal cancer, treated with oxaliplatin, with CIPN grade > 2 for more than 3 months. All will receive: standard treatment + 40 sessions of rectal insufflation of O3/O2 over 16 weeks:

  • Ozone Arm (n=21): O3/O2 concentration increasing from 10 to 30 μg/ml.
  • Control-Placebo Arm (n=21): O3/O2 concentration = 0 μg/ml.

Treatment duration: 16 weeks. Follow-up: 12 weeks after the completion of O3/O2 insufflations. Total Project Duration: 36 months.

Primary Variables: Evolution at the end of insufflations with O3/O2 of: 1) “average pain” from CIPN according to the Brief Pain Inventory-Short Form; 2) HRQoL and utilities using EQ-5D-5L and SF-36 quality of life questionnaires; 3) Direct costs.

Assessments at weeks: 0 (baseline), 16 (end of O3/O2 insufflations, target), and 28 (end of follow-up, control).

Contact Person: Bernardino Clavo Varas