A randomized phase II study for tertiary prevention of squamocellular cancer of head and neck (SCCHN) with a dietary intervention
Survival rate for patients with locally advanced high risk 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, second tumors and treatment related late sequelae. In epidemiological studies, diet is reported to play a major role as 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 cheap and non toxic method, widely and easily affordable in all EU countries, and the identification of reliable biomarkers that may improve its efficiency constitute the basis of this project. In one year prospective randomized trial, 350 effectively cured, stage III-IV HNSCC survivors from 6 different countries will be enrolled. The study includes 2 intervention arms: an experimental arm, with a highly monitored and specific dietary intervention based on AICR/WCRF recommendations for cancer prevention and a control arm based on standard recommendations. Clinical endpoints are: incidence reduction of tumor recurrence and second primaries; improvement of quality of life in HNSCC survivors. Translational endpoints are: miRNAs identification and their changes in saliva and blood; identification of cytokine and growth factors in blood and inflammatory cytokine profile changes; time course of saliva monitoring of DNA methylation.
Funded by the European Union under the Horizon Europe Framework Programme - Grant Agreement Nº: 101095654. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.