A multinational consortium to implement a dietary intervention in cancer survivors

Place: Milano, italy, Europe
Food consumption patterns: diet, environment, society, economy and health Food consumption patterns: diet, environment, society, economy and health
Total Budget: € 250,00 | Period: From February 2014 To


This project aim at developing a multinational consortium for the implementation of a nutritional strategy for cancer survivors in order to answer to quality of life needs and to reduce second primaries and recurrences.There is a strong need for effective tertiary prevention of head and neck squamous cell cancer (HNSCC). In recent prospective studies, index-based dietary patterns showed an inverse relationship with HNSCC development. In this framework the creation of a multinational consortium in order to implement 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 the main project. A total of 350 effectively cured, stage III-IV HNSCC survivors from 6 different countries will be enrolled in a prospective randomized trial.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.


Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy

Lead applicant

Clincial and translational research regarding cancer disease

Grupo de Estudos de Cancro (da Cabeça e Pescoço) - Portugal

Initiative partner

Clinical research in medical oncology with particilar interest in translational research.

Medical University - Austria

Initiative partner

Clinical and translational research in medical oncology.

Institute of Oncology - Slovenia

Initiative partner

Clinical and translational research in medical oncoloy.

University of Leipzig - Germany

Initiative partner

Clinical and translational research in medical oncology.

University of Medical Sciences, The Greater Poland Cancer Centre - Poland

Initiative partner

Clinical and translational research in medical oncology.

Istituto Nazionale Tumori Regina Elena - Italy

Initiative partner

Clinical and translational research in medical oncology.

Spedali Civili di Brescia - Italy

Initiative partner

Clinical and translational research in medical oncology.

A Nutritional approach and dietary guidelines for cancer survivors in an international context

This international project aims at providing the best possible information to help cancer survivors and their families to make informed choices about nutrition and healthy lifestyles to prevent recurrence or second primary cancers as well as to improve quality of life. This trial will constitute the basis for demonstrating the efficacy of dietary intervention in HNSCC survivors. The detection and monitoring of selected miRNA and inflammatory cytokines during dietary intervention will be useful to ascertain compliance and the relationship with clinical outcomes, possibly identifying subjects at risk. Moreover, the city of the Coordinating Center, Milan, will host the EXPO Universal exposition that will be held under the theme: “Feeding the planet, energy for life”. Therefore, this will be a unique occasion to communicate innovations in dietary intervention as a way for tertiary prevention of HNSCC.

Makesense campaign Cancers of the head and neck are the sixth most common cancer in Europe. This is about half of lung cancer, but two times more common than cervical cancer. There were more than 150,000 new cases diagnosed in Europe in 2012, which is the equivalent of twice the capacity of the Olympic Stadium in London. Despite its severity and increasing prevalence in society, there is little awareness of cancer of the head and neck, and the results of treatment are still unsatisfactory; it is essential to focus attention and raise awareness on the importance of prevention.

There is a growing interest from the scientific community as well as from the society to consider diet as a tool to improve wellness and health. Recent studies have suggested that diet and exercise interventions ameliorate adverse sequelae of cancer, its treatment, as well as cancer-specific survival and overall survival. Lifestyle is considered to exert major influence on potentially improving cancer survivorship, just as it is essential for cancer prevention. Key dietary recommendations include to increase the consumption of fruits and vegetables, to prefer whole grains over refined grains, fish and poultry over red and processed meats, unsaturated fats over saturated and low-fat over full-fat dairy. Consumption of junk food rich in trans fatty acids is associated with higher incidence of several cancers. Several studies examined lifestyle and metabolic factors before diagnosis with prognosis, showing that fruit, vegetable and fibre consumption are associated with better prognosis.

Head and neck cancer: epidemiology, causes, symptoms and diagnosis. "Cancers of the head and neck" is a way of describing any type of cancer that origins in the region of the head or neck, with the exception of the eyes, brain, ears and esophagus. It usually originates in the cells lining the surface of the head and neck, such as the mucosa of the mouth, nose and throat. The main risk factors are: Smoking - smokers have a higher risk of incidence of head and neck cancer than the non-smokers; Drinking - men who consumed more than three units (250 ml wine 12% vol) and women who consume more than two units of alcohol (175 ml wine 12% vol) per day had a significantly higher risk of developing cancer of the head and neck; HPV - incidence of throat cancer is related to some subtypes of HPV viruses.
Nutrition and cancer A growing number of studies are demonstrating the importance of a healthy diet in the prevention of cancer. In some cases, this depends on the presence of some substances in foods that could promote the development of the disease. There are now a lot of evidence that a healthy diet should be followed and healthier lifestyles shuold be pursued in order to prevent tumors and other diseases.
What is the relationship between alcohol and cancer? It takes 50 grams of alcohol a day, the equivalent to a little more than three glasses of an alcoholic beverage, to increase two to three times the risk of the oral cavity, pharynx and esophagus cancers compared to the non-drinkers. Also 50 grams per day is the amount sufficient to increase by 50 percent the risk of breast cancer in women, although it takes only 18 grams to record a first increase in risk compared to the teetotal. With the same amount of alcohol the chance of developing colorectal cancer than those who never drinks are increased by 40 percent.

Since February 2014 a multinational consortium has been implemented involving 5 countries (Italy, Austria, Poland, Portugal and Slovenia) in order to spread a global nutritional approach for cancer survivors. Moreover, at the italian level, 3 research centers with recognized expertise are involved in this project (Fondazione IRCCS Istituto Nazionale dei Tumori, Spedali Civili di Brescia and Ospedale Regina Elena Roma). The strenghts of the consortium partners lays on the expertise in  cancer treatment; demonstrated capability to conduct clinical studies; sensitivity to the core question of the interventional approach; interest in translational innovative research; proven attitude for multidisciplinary activity collaboration.The consortium includes all the involved disciplines and at the level of the single participating center there is always a tight connection among project's relevant disciplines/expertise (eg radiation oncologist and nutritionist, surgeon and biologist).

Nutritional intervention and dietary guidelines are addressed to head and neck cancer survivors in order to prevent second primaries and recurrences through a healthier lifestyle approach as well as to ameliorate their quality of life. In addition caregivers are involved as beneficiaries of the initiative. All the participants are involved in several training activities aimed at spreading the interventional dietary approach throughout the different countries. For this activities we rely on our experience on intervention diet programs and prospective studies led by Dr Franco Berrino. Targets of the nutritional approach are also the care providers involved in the project, that are enthiusiastic in taking part in such an initiative; experts from the coordinating center are in tight contact with the nutritionist of each center in order to spread the dietary intervention.

The main consortium is composed by: 6 medical oncologists, 4 surgeons and 4 radiotherapists. They are responsible as support staff  for clinical trial management, patients recruitment, clinical trial visits and assessments as well as performing and maintaining the communication and information exchange between the centers taking part in the trial. Six nutritionists for counseling and responsible for the support of dietary intervention training; 5 pulmonoligists for counseling; 6 biologists responsible for blood samples and saliva samples collection and for performing the laboratory analyses; 4 project managers for activities related to local authorities submission and contract management tasks for the participating centers; 4 data managers for data management, data entry, queries generating and data reconciliation; 3 statistician for interim analysis, data analysis and results eaboration.

Patients in the control arm may follow the same dietary intervention as the experimental arm. We will gather all information regarding changes in lifestyle and food frequency from all patients.. The specific questionnaires administered regarding dietary compliance are being evaluated for the first time in head and neck cancer patients. Difficulties related to the patient’s comprehension or ability to answer may be encountered. In this case, corrective actions will be employed. Adherence to nutritional guidelines could represent one of the most relevant problems, especially since dietary intervention is expected to be continuous throughout the study period. The identification of such behaviors and possible corrective strategies to avoid poor diet compliance is considered to be a necessary factor. Several interventions have been foreseen to increase adherence (kitchen classes, monthly newsletter, nutritional counseling at each follow-up visit).

This project aims at assessing the effectiveness and the need of providing the best possible information with which help cancer survivors and their families to make informed choices related to nutrition and healthy lifestyles in order to prevent recurrence or second primaries. Health care providers will have an unique opportunity to guide cancer patients towards optimal lifestyle and nutritional choices, by favorably influencing the survivorship trajectory. In this frame physicians will plant an appropriate message and then refer patients to registered dietitians or nutritional consultants. The identification of a dietary intervention for tertiary prevention may also favorably impact on quality of life and constitutes an easy and transferable strategy to improve outcome of this cancer population. This project will constitute the basis for demonstrating the activity and feasibility of such an approach in cancer survivors across different European countries.

Anti-inflammatory diet Cancer cells, unlike normal cells, grow best in inflamed tissues, in order to limit inflammation processes, the best strategy is lifestyle and diet. The anti-inflammatory diet avoids red meat and prefers fish. Thus limits the omega 6 and increase the omega 3 which abound in small fish in our seas, perhaps contaminated but with no time to absorb too many heavy metals.
Interview with Dr. Franco Berrino The importance of nutrition in order to prevent cancer and other diseases. An example of what is considered "nutritionally correct": guidelines that everyone shoul follow in order to pursue a healthier lifestyle.

New scientific evidence has emerged on the relationship between nutrition, healthy lifestyle, quality of life, comorbidities, cancer recurrence, second primary cancers development, and overall survival. Although this evidence is incomplete, reasonable recommendations can be made on several aspects that can guide choices about foods, lifestyle, and dietary supplement use. This project could be able to give strength to this assumptions and will constitute the basis for demonstrating the activity and feasibility of such an approach across different European countries. If the endpoints will be met, then larger phase III trials should be launched also in other cancer settings and diseases. Moreover the detection of selected miRNA and inflammatory cytokines during dietary intervention might be useful to ascertain its effectiveness. With such a translational approach, a nutritional educational strategy could be applied as a tailored treatment in subjects at risk. 

We envisage the opportunity of developing and disseminating a feasible and easily diet accepted by different cultures according to their own traditions. This will allow exploiting study results at a population based level. Project results will be reported at oncological meetings and congresses, supportive care and nutritional meetings. European Cancer Patients coalition that is currently implementing a head&neck cancer task force, as well as national advocacy groups will be contacted. The makesense campaign www.makesensecampaign.org will help in spreading results as well as media which will be contacted by the consortium. The city of the Coordinating Center, Milan, will host the EXPO with the theme: “Feeding the planet, energy for life”. It will be an exceptional occasion to spread the scientific background. Also the feasibility of producing a multimedial App including dietary suggestions will be explored.