OI Ljubljana

A randomized phase II study for tertiary prevention of squamocellular cancer of head and neck (SCCHN) with a dietary intervention

Principal investigator at the Institute of Oncology Ljubljana: Primož Strojan PhD

Survival rate for patients with HPV negative Head and Neck Squamous Cell Cancer (HNSCC) is not substantially improved in the last years and it remains unsatisfactory, in particular for stage III-IV patients, despite the introduction of new therapeutic strategies. There is a strong need for effective preventive approaches that could be implemented after completion of curative treatment to reduce the recurrences and second tumor incidence. In epidemiologic 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. 

The activity of a dietary intervention as a low-cost and non toxic method, thus affordable for the vast majority of EU countries, and the identification of reliable biomarkers improving trial 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 will foresee two arms of treatment: 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 in the incidence of tumor recurrence and second primaries. The primary translational endpoint will focus on the identification of miRNAs in saliva and blood and evaluation of their change in the arms of treatment. The study is planned to enroll 178 patient per arm.



© 2019 - Institute of Oncology Ljubljana
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