Control-placebo- Arm (n = 21): concentration of O3/O2 = 0 μg/ml.
Ozone-Arm (n = 21): concentration of O3/O2 increasing from 10 to 30 μg/ml.
TREATMENT: All patients will receive: usual treatment + 40 rectal insufflation sessions of O3/O2 in 16 weeks: METHODOLOGY: Randomized controlled trial (RCT) phase II-III, randomized, triple-blind 42 patients with cancer of the colon and rectum, treated with oxaliplatin, with CIPN of grade > = 2 for > = 3 months. Secondary Objectives: To evaluate the evolution of: 3) oxidative stress and chronic inflammation through biochemical measurements 4) anxiety and depression of patients 5) the diagnostic and predictive value of hyperspectral imaging in the assessment of pain 6) the acceptability of patients to a shared decision-making (SDM) tool. 2) Estimate the additional costs and evaluate the cost-effectiveness ratio. Main Objectives: 1) To evaluate the clinical effect and on the health-related quality of life (HRQOL) of adding ozone to the usual patient´s treatment with persistent pain because of CIPN. The therapeutic measures for the CIPN are very limited in its number and efficacy.
Why Should I Register and Submit Results?Ĭhemotherapy-induced peripheral neuropathy (CIPN) decreases the quality of life of patients and can lead to a decrease and/or interruption of chemotherapy treatment-limiting its effectiveness.
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