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