Breast  cancer  is  the  second leading cause  of  death  in  women  and  accounts  for  11%  of  cancers detected  in  Spain.  The  improvements  in  diagnosis  and  treatments  have increased the  survival  of these  patients,  making  it  necessary  to  accelerate  the  subsequent  recovery  and  the quality  of  life that,  therefore,  would  reduce  healthcare  costs. Deficiencies  at  immune, nutrition,  and  cognitive levels, as well as the presence of neuropathic pain negatively impact quality of life in cancer patients. Moreover, as gut microbiota implication in cancer becomes relevant it is still unknown the beneficial impact of its modulation in breast cancer patients. In recent years it has been found that the latter can be modulated by compounds with prebiotic activity such as those from certain fungal species. Some   compounds   are   also   capable   of   stimulating   the   immune   system   and   alleviating myelosuppression caused by radio and chemotherapeutics.

Based on this background, the project proposes the development and functional validation of a new food supplement from fungal extracts, capable of influencing the intestinal microbiome, improving nutrient  absorption  and  stimulating  the  immune  response,  improving  evolution/recovery  of patients who have suffered breast cancer.

For this, there are three complementary partners with extensive experience in each of the technical aspects, which will cover the different objectives of the project: Hifas da Terra, based on their prior knowledge  and in  vitrofunctionality  tests,  will  develop  and  produce  a  new  food  supplement (ACTIVITY 1), which will be validated following a dual strategy to cover all the most relevant aspects of  the  potential  benefits  of  the  product:  i)  two  preclinical  studies  in  the  natural  model  of  canine cancer,  and  in  the  murine  model  with  cancer  of  orthotopic  breast  and  humanized  intestinal microbiome  from  samples  of  the  control  and  diagnosed      breast  cancer  patients,  for  optimum extrapolation and outcome prediction in clinical target  (ACTIVITY 2), and ii) a clinical trial in breast cancer patients during various stages, from diagnosis to recovery after treatment, where multiple parameters, including immune   function   and   gut  microbiota   composition  will   be  monitored (ACTIVITY 3). Preclinical studies will allow evaluating relevant aspects that could not be approached from  the  clinic  (for  cost,  ethics  or  feasibility),  such  as  the  relationship  between  tumor  evolution, microbiome and neuropathies or histology, as well as the effectiveness of the new product when starting  its  administration  at  different  times  of  treatment  (before/after  chemotherapy).  For  such studies, omic techniques (metagenomics, metabolomics) and classic biomarkers will be used, which, together with the other results, will allow to determine the functionality, mechanisms of action and efficacy of the new food supplement.

The competitiveness of the consortium and the commercial capacity of the participating company will facilitate the  rapid entry  into the market of new products, having a positive impact on short-term health. The project, with a duration of 42 months, is divided into 3 activities and has a budget of 1,025,768.31€.

Project Budget: 1.025.768,31€

Leitat Budget: 220.613,87€

Financial Framework: RTC

Contract number: RTC2019-007402-1

Start Date: 01/07/2020

End Date: 31/12/2023


Contact Manager: I. Ortiz 

Proyecto RTC2019-007402-1 financiado por MCIN/AEI/10.13039/501100011033.