CI-PERINOMS: Chemotherapy Induced - Peripheral Neuropathy Outcome Measures Study.

Chemotherapy-induced peripheral neuropathy (CIPN) is a major and potentially dose-limiting adverse event of several chemotherapeutic agents (Windebank and Grisold, 2008). CIPN is characterized by distal symmetrical numbness, tingling, paresthesias, dysesthesias, pain and/or weakness, which significantly affect functionality and quality of life (Aaronson, 1998). The incidence of CIPN may be as high as 100% in treated patients, depending on dose and dose-intensity of the chemotherapeutic regimen. The neurotoxic side effects may be permanent, and treatment is usually difficult. Neuroprotective agents that would either prevent or ameliorate CIPN are currently under investigation (Cavaletti and Marmiroli, 2006; Albers et al., 2007). However, before studying these agents in clinical trials, it is crucial to be able to assess CIPN in a simple, valid, and reproducible way in accordance with postulated international guidelines (Hobart et al., 1996; Merkies and Lauria, 2006). Although several scales have been used by oncologists and neurologists, grading CIPN is still an unsolved issue (Postma and Heimans, 2000; Cavaletti et al., 2007).Moreover,most of the scales have not undergone rigorous clinimetric evaluation and analysis, which are nowadays essential requirements for any proposed clinical trial (van Nes et al., 2008). The CI-PERINOMS: Chemotherapy Induced-Peripheral Neuropathy Outcome Measures Study protocol was developed by experienced neurologists to identify the best method(s) to assess and monitor CIPN (Cavaletti, 2008).