SICILY

Neurotoxic systemic cancer treatments can lead to persistent cancer treatment-induced peripheral neuropathy (CIPN), causing sensory, motor and autonomic impairments that negatively affect activities of daily living (ADL) and quality of life (QoL). A personalized and supervised multimodal exercise program may be an effective way to reduce CIPN burden, improve physical functioning and enhance quality of life. The SICILY study is a multicenter randomized controlled trial aiming to include 136 participants with persistent CIPN after neurotoxic systemic cancer treatment that experience CIPN interference in ADL. Participants will be randomized to either an intervention group receiving a 12-week supervised CIPN-specific exercise intervention, or a wait-list control group receiving the same intervention after a 12-week control period. The multimodal exercise program consists of CIPN-specific exercises combining balance, continuous aerobic and resistance exercises twice per week, supervised by a physiotherapist; goal-directed occupational therapy; home-based balance training supplemented with daily hand/feet exercises; and the recommendation to walk ≥30 minutes on days without scheduled exercise sessions. The primary objective is to evaluate the effectiveness of this multimodal exercise intervention in reducing patient-reported CIPN burden. Secondary outcomes include CIPN symptoms, disability, fear of falling, fear of movement, distress, fatigue, QoL, physical performance, physical activity, fine dexterity, participant-specific goals, compliance, cost-effectiveness and participants’ experience with the intervention.