Tertiary prevention of HNSCC with a dietary intervention (DietINT)

Survival rate for patients with locally advanced HPV negative Head and Neck Squamous Cell Cancer (HNSCC) is not substantially improved in the last years and it remains unsatisfactory, despite the introduction of new therapeutic strategies. There is a strong need for effective preventive approaches to reduce incidence of recurrences and second tumors. In epidemiological studies, diet is reported to play a major role as a risk factor for HNSCC development and in a large prospective study, index-based dietary patterns showed an inverse relationship with the development of HNSCC. A specific dietary intervention as a low-cost and non- toxic method, thus widely and easily affordable in all EU countries, and the identification of reliable biomarkers improving its efficiency constitute the basis of this project. Effectively cured, stage III-IV HNSCC will be enrolled in one year from 6 different countries and will be followed for at least 24 months. The study foresees two intervention arms: the experimental arm, with a dietary intervention based on the AICR/WCRF recommendations for cancer prevention and a control arm based on standard recommendations. The primary clinical endpoint is the reduction of tumor recurrences and second primaries. The primary translational endpoint aims at the identification and intervention induced changes of miRNAs in saliva and blood. The study is planned to enroll 178 patients per arm.