The therapeutic power of fasting against cancer. “The first study in the world” starts in Italy which will evaluate the effects of caloric restriction – compared with a healthy and balanced, but not restrictive, diet – on patients eligible to receive pre-surgical chemo-immunotherapy treatment against triple breast cancer negative. The worst of the breast cancers, affecting 10-15% of breast cancer patients. The trial will allow us to clarify not only the impact of caloric restriction on cancer, compared to a different dietary pattern, but will also allow us to analyze how 'fasting-like' influences the outcomes of pharmacological treatments. The study, coordinated by the National Cancer Institute (Int) of Milan, will last 2 years; It's called Breakfast-2 and will enroll about 150 women aged 18 to 75. Twelve centers involved in the Peninsula. Among the peculiarities of the project there is also the use of a web-app which will keep patients and doctors in direct contact via chat.
“The launch of this study represents an important historical moment for our research team – states Filippo de Braud, director of the Department of Oncology and Hematology of the Int, full professor at the State University of Milan – The nutritional scheme of calorie restriction it has always been the same since 2016 and in these 8 years it has been the subject of studies involving a total of more than 250 patients, mainly with breast cancer. We have demonstrated that with this approach it is possible to obtain a favorable remodulation not only of the metabolism , but also of the immune system, 'boosting' immune cells with anti-tumor activity. Now we are in a subsequent phase of the experiment, in which we are evaluating the impact of this nutritional program on the anti-tumor activity of pharmacological treatments.” In the specific case, of a treatment based on 4 chemotherapy drugs and an immunotherapy, administered before surgery to patients with early stage (II-III) triple negative breast cancer.
“The Breakfast-2 study represents an interesting challenge because, for the first time – highlights Giovanni Apolone, scientific director of the Irccs Int Foundation – the nutritional approach is evaluated in a study that includes a control arm, as commonly carried out in studies. It is also essential to underline the presence of the web-app, which incorporates the concept of patient-reported outcomes, essential for our institute, which has always had the well-being of the patient in its mission.”
The cyclical caloric restriction scheme – they recall from the Int – involves a 5-day diet based on foods and fats of plant origin and a low carbohydrate and protein content, which is repeated every 3 weeks. In the control arm of the new trial, the recommended diet is based on the use of a wide variety of unrefined cereals, predominantly vegetarian, as per the indications of the main international scientific societies (Word Cancer Research Fund; European Code Againist Cancer; American Cancer Society). All Breakfast-2 patients will follow pre-surgical chemo-immunotherapy.
“It is the first time that we combine such a complex therapeutic scheme with a nutritional program that involves caloric restriction – says Claudio Vernieri, medical oncologist at the Breast Unit of the Department of Oncology and Hematology of the Int, researcher of UniMi and the Firc Institute of molecular oncology (Ifom) – The aim is to evaluate whether the caloric restriction approach is safe, well tolerated and, above all, whether it is able to increase the anti-tumor activity of chemoimmunotherapy. Women enrolled in the control arm will be offered a nutritional program which is the best dietary behavior known to date. These patients – he specifies – will be monitored from an oncological and nutritional point of view with the same frequency and method as the patients enrolled in the experimental arm. Therefore these patients will also benefit from joining the study “.
All patients recruited in the Breakfast-2 study will also be followed via a web-app created by Int researchers in collaboration with Eurama Precision Oncology. “The web-app was designed on the basis of the experience gained with the women involved in our previous studies – explains Francesca Ligorio, medical oncologist at the Breast Unit of the Department of Oncology and Hematology of the Int and Ifom researcher – From the app they can have the various teams of the centers involved also have access, but it is the Int that provides assistance to the patients in case of need or doubts”, with its oncologists and nutritionists. “The advantage is that it allows us to have a real-time global idea of the progress of the study, the patients' adherence to the treatment, any side effects and the health status of each person involved, without intermediate steps.”
Among the objectives of the study there is also the search for molecular biomarkers. “We evaluate the evolution of genomic and gene expression profiles at the level of the tumor tissue, and the association between these and the tumor's response to experimental treatments – concludes Giancarlo Pruneri, director of the Department of Advanced Diagnostics of the Int and president of Eurama Precision Oncology – Any biological characteristics that emerge will allow us to identify possible biomarkers of sensitivity or resistance to the proposed treatments and, therefore, also to hypothesize tumor resistance mechanisms to be studied in our laboratories to improve the effectiveness of this therapeutic approach”.
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