A topical nociceutical formulation ameliorates chemotherapy-induced peripheral neuropathy: a pilot randomized clinical study.

Abstract

Background: Up to 80% of patients undergoing taxanes or platinum-based chemotherapy (CT) develop a peripheral polyneuropathy (CIPN), that affects treatment compliance and quality of life (QoL). CIPN is characterized by a remarkable sensitization of peripheral nociceptive endings. We performed a proof-of-concept, double-blind, randomized, two-arms, multicenter clinical study to evaluate if protecting epidermal nociceptive endings with a topical nociceutical formulation prevented CIPN and augmented QoL during CT.

Material and methods: Participants started a daily topical application of the assigned formulation in hands (moisturizing or nociceutical). Upon appearance of neuropathic symptoms in hands or feet, they applied the creams twice daily. Diagnosis and follow-up of CIPN was performed using the CTC AE v5.0 criteria.

Results: A cohort of 142 patients treated with taxanes and/or platinum agents were randomly distributed into the arms. Withdrawals were similar in both arms. A lower CIPN incidence in hands was observed in the nociceutical arm (32% vs 13%, p = 0.03), while a similar number of participants developed CIPN in feet (73% vs 67%, p = 0.1). Interestingly, the nociceutical formulation increased the number of CT cycles CIPN free (6 vs 8 cycle, p = 0.009). The Leonard Scale Questionnaire revealed that 60% of patients using the moisturizing cream reported frequently bothersome neuropathic symptoms, compared with only 39% in the nociceutical group (p = 0.0017).

Conclusion: Protection of nociceptive epidermal terminals with a topical nociceutical formulation reduced the incidence of CIPN in hands and increased the QoL of patients. These findings provide a solid ground for a confirmatory clinical study.