NCI Clinical Trials Planning Meeting for prevention and treatment of chemotherapy-induced peripheral neuropathy.

Although recent scientific advances have improved our understanding of basic biological mechanisms underlying chemotherapy-induced peripheral neuropathy (CIPN), few interventions are available to prevent or treat CIPN. While some biological targets from preclinical studies show promise in non-human animal models, few targets have been translated to successful clinical trials. To address this problem, the National Cancer Institute's (NCI's) Symptom Management and Health-Related Quality of Life Steering Committee convened a meeting of experts in the CIPN and oncology symptom management fields to participate in a Clinical Trials Planning Meeting (CTPM). Investigators presented data from preclinical and translational studies for possible CIPN interventions; these were evaluated for readiness of randomized clinical trial testing by experts, and recommendations were provided. Breakout sessions were convened to discuss and develop future studies. The CTPM experts concluded that there is compelling evidence to move forward with selected pharmacological and non-pharmacological clinical trials for the prevention and treatment of CIPN. Several key feasibility issues need to be addressed, however. These include: identification of optimal outcome measures to define the CIPN phenotype, establishment of parameters that guide the evaluation of clinically meaningful effects, and adoption of approaches for inclusion of translational and biomarker/genetic measures. The results of the CTPM provide support for conducting clinical trials that include both pharmacological and non-pharmacological approaches, alone or in combination, with biomarkers, genetics or other measures designed to inform underlying CIPN mechanisms. Several working groups were formed to design rigorous CIPN clinical trials, the results of which are ongoing.