Prevención con restricción del flujo sanguíneo sobre la incidencia de toxicidad neural en cáncer de mama (PRESIONA):Ensayo clínico controlado y aleatorizado durante quimioterapia neoadyuvante

Résumé

Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting toxicity for many commonly used anticancer agents. It is generated by axonal and dorsal root ganglion damage, predominately is a sensory neuropathy and may influence survival and quality of life. Physical exercise programs appear to be feasible and effective at reducing CIPN symptoms. However, in fact, so far CIPN treatment still no cure and lacks robust evidence both for pharmacological and non-pharmacological. Thus, the impact of CIPN has led researchers and clinicians to question which dose of physical exercise is more suitable in patients with cancer for prevention of CIPN. This Doctoral Thesis aims to contextualise the state-of-the-art of physical exercise to prevent CIPN in patients with cancer (Study I) and to propose a physical exercise program plus blood flow restriction (BFR) with the capacity to prevent neuropathy (PRESIONA) (Study II). For Study I, a systematic review with meta-analysis was carried out to analyze the effects of physical exercise applied before or during chemotherapy to prevent or ameliorate CIPN in randomized controlled trials. Medline, Web of Science, Scopus, and Cochrane Library were searched. Two reviewers blinded and independent found eight studies (a total of 618 patients with cancer). None of the studies achieved a “low” overall risk of bias. Four studies were included in meta-analysis for quality of life, and a significance standardized mean difference was found between groups from baseline of 14.62; 95% CI, 6.03-3.20, with a large effect size g=0.83; 95% CI, 0.48-1.18) in favor of physical exercise program compared with usual care. Physical exercise at the onset of chemotherapy has shown promising effects on the prevention of CIPN, specially improving quality of life. However, the diagnosis of CIPN is not avoided with the proposed physical exercise programs in all patients; the severity of symptoms can be reduced. For that reason, looking to the evidence of the physiological potential of BFR plus physical exercise on other disorders, it is proposed analysing the effects of PRESIONA (Study II) to prevent CIPN in women with early breast cancer undergoing neoadjuvant chemotherapy. PRESIONA will be a physical therapist-led multimodal exercise program that uses BFR during low-load aerobic and strength exercises. Feasibility will be quantified and in the efficacy study, the main outcome will be EORTC QLQ-CIPN20. The innovative approach of this study could have a far-reaching impact on therapeutic options, and the physical therapist role could be essential in the oncology unit to improve quality of life in individuals with cancer and reduce side effects of cancer and its treatments.