{"id":9733,"date":"2024-08-13T09:33:04","date_gmt":"2024-08-13T09:33:04","guid":{"rendered":"https:\/\/sescs.es\/?page_id=9733"},"modified":"2024-08-13T09:33:04","modified_gmt":"2024-08-13T09:33:04","slug":"effectiveness-and-cost-effectiveness-of-ozone-in-the-management-of-patients-with-chemotherapy-induced-peripheral-neuropathy-pain-randomized-triple-blind-clinical-trial","status":"publish","type":"page","link":"https:\/\/sescs.es\/en\/effectiveness-and-cost-effectiveness-of-ozone-in-the-management-of-patients-with-chemotherapy-induced-peripheral-neuropathy-pain-randomized-triple-blind-clinical-trial\/","title":{"rendered":"Effectiveness and cost-effectiveness of ozone in the management of patients with chemotherapy-induced peripheral neuropathy pain: randomized, triple-blind clinical trial."},"content":{"rendered":"<p><strong>Full Title<\/strong>: Effectiveness and cost-effectiveness of ozone in the management of patients with chemotherapy-induced peripheral neuropathy pain: randomized, triple-blind clinical trial.<\/p>\n<p><strong>Funded by<\/strong>: Instituto de Salud Carlos III (FIS PI19\/00458)<\/p>\n<p><strong>Grant awarded<\/strong>: \u20ac56,265.00<\/p>\n<p><strong>Duration<\/strong>: 3 years (01\/01\/2020-31\/12\/2022)<\/p>\n<p><strong>Principal Investigators<\/strong>: Bernardino Clavo Varas, Delvys Rodr\u00edguez Abreu<\/p>\n<p><strong>Collaborating Researchers<\/strong>: Miguel \u00c1ngel Carames \u00c1lvarez, Francisco Javier Rodr\u00edguez Esparrag\u00f3n, Oliver Rivero Arias, Saray Galv\u00e1n Ruiz, Teresa T\u00e9llez Santana<\/p>\n<p><strong>Objectives<\/strong>:<\/p>\n<p>Chemotherapy-induced peripheral neuropathy (CIPN) reduces patients&#8217; 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.<\/p>\n<p><strong>PRIMARY OBJECTIVES<\/strong>: 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.<\/p>\n<p><strong>SECONDARY OBJECTIVES<\/strong>: 3) To assess the evolution of biochemical markers of oxidative stress and chronic inflammation.<\/p>\n<p><strong>Methodology<\/strong>:<\/p>\n<p>Phase II-III clinical trial, randomized, triple-blind; 42 patients with colon and rectal cancer, treated with oxaliplatin, with CIPN grade &gt; 2 for more than 3 months. All will receive: standard treatment + 40 sessions of rectal insufflation of O3\/O2 over 16 weeks:<\/p>\n<ul>\n<li><strong>Ozone Arm<\/strong> (n=21): O3\/O2 concentration increasing from 10 to 30 \u03bcg\/ml.<\/li>\n<li><strong>Control-Placebo Arm<\/strong> (n=21): O3\/O2 concentration = 0 \u03bcg\/ml.<\/li>\n<\/ul>\n<p><strong>Treatment duration<\/strong>: 16 weeks. Follow-up: 12 weeks after the completion of O3\/O2 insufflations. Total Project Duration: 36 months.<\/p>\n<p><strong>Primary Variables<\/strong>: Evolution at the end of insufflations with O3\/O2 of: 1) \u201caverage pain\u201d 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.<\/p>\n<p><strong>Assessments at weeks<\/strong>: 0 (baseline), 16 (end of O3\/O2 insufflations, target), and 28 (end of follow-up, control).<\/p>\n<p><strong>Contact Person<\/strong>: Bernardino Clavo Varas<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Full Title: Effectiveness and cost-effectiveness of ozone in the management of patients with chemotherapy-induced peripheral neuropathy pain: randomized, triple-blind clinical &hellip; <\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[],"tags":[],"class_list":["post-9733","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Effectiveness and cost-effectiveness of ozone in the management of patients with chemotherapy-induced peripheral neuropathy pain: randomized, triple-blind clinical trial. | SESCS<\/title>\n<meta name=\"description\" content=\"El Servicio de Evaluaci\u00f3n y Planificaci\u00f3n del Servicio Canario de la Salud (SESCS) es una unidad dependiente de la Dir. del Servicio Canario de la Salud en la Cons. de Sanidad del Gobierno de Canarias, constituido por investigadores economistas, epidemi\u00f3logos, psic\u00f3logos, soci\u00f3logos, antrop\u00f3logos, 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