Clinical trial for chemotherapy-induced peripheral neuropathy: Supportive care using medical devices

Abstract

Abstract Effectiveness of supportive care intervention is often influenced by large variability in pharmacokinetics and pharmacodynamics of anti-cancer drug, which is difficult to adjust. Within-person design is useful and efficient to eliminate biases arising from such variabilities and unmeasurable risk factors if the primary endpoint events occur symmetrically, the intervention only affects to the targeted body parts and the baseline data can be used for the comparison. For example, cooling devices (frozen gloves and socks) to prevent chemotherapy-induced peripheral neuropathy (CIPN) or skin and nail toxicity are applied to intervention limbs and compared to the control limbs in the within-person design clinical trials. Although it is necessary to pay attention to the validity of comparisons and appropriate measurements of outcomes, the within-person design is a useful clinical trial design when investigating preventative efficacy regarding adverse effects with minimum sample size. The design should be suited to archive the resource-limited supportive care research setting such as medical devices development because it contributes to reduce the trial costs and rapidly make evidence following the development of new anti-cancer treatment.