Étude QUALIOR : faisabilité et efficacité d’un programme d’activité physique adaptée standardisée et encadrée à domicile chez des patients bénéficiant d’une thérapie ciblée orale pour un cancer métastatique: Essai de phases II–III randomisé de l’intergroupe Unicancer–AFSOS soins de support

Abstract

The adverse effect most commonly reported by patients treated with oral targeted therapies for advanced cancer is the onset of fatigue, which may be a limiting factor in long-term tolerance of these treatments. Adapted physical activity (APA) has a demonstrated its beneficial effect on the level of fatigue experienced by patients treated for localised cancer and, under certain circumstances, has shown an improvement in survival. The majority of studies were conducted in the post-cancer period or during the treatment phase, with chemotherapy and/or radiotherapy. Very few studies have been carried out on patients treated with oral targeted therapies. APA programmes vary in quality in terms of their objectives and the ways in which they are carried out and assessed. Particularly for patients with fatigue who have an advanced illness, it is important to assess supervised, home-based APA programmes. The QUALIOR study, sponsored by Unicancer, is a phase II–III randomised study, with the aim of thoroughly assessing the implementation of a 3-month home-based APA programme for more than 300 patients treated with targeted therapy for an advanced cancer (including breast, kidney and lung cancer plus a diverse cohort) in improving fatigue and quality of life, as well as full-term treatment compliance. A secondary objective is to evaluate progression-free survival. This programme is also assessed for its medico-economic relevance. The feasibility of the APA programme, which has been designed with various intensity levels, is assessed during the phase II study, which will then be continued with a phase III study to measure the programme’s efficacy. The final objective is to provide access to supervised APA sessions, specifically aimed at patients treated with these new targeted therapies, within the framework of a supportive care activity.