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- Hifas da Terra (HdT), a leading multinational biotech company in the development of natural products for human health made from medicinal mushrooms, is evaluating the impact of its ‘Mico-Mama 2.0’ formula on breast cancer patients through a new clinical trial supported by the Instituto de Investigación Sanitaria Galicia Sur (IISGS). This trial, which is part of the collaborative Microinmunomama project, led by HdT since 2019, will measure several health and quality of life parameters in more than 100 breast cancer patients. Thus, this oncological clinical study is a milestone in the research into the use of medicinal mushrooms in the fight against breast cancer.
- This clinical trial is being carried out at the Vigo University Hospital Complex (CHUVI), in the Vigo Health Area, which is the headquarters of IIS Galicia Sur (IISGS). Dr. Esteban Castelao is the principal investigator of the study who, with Dr Víctor Muñoz, directs the Genetic Oncology, Radiobiology and Radiointeraction Unit of the IISGS research institute. The trial is being funded by the Spanish Ministry of Science and Innovation through the Retos colaboración programme as part of the HdT led Microimmunomama project, in partnership with IISGS. It is a long term research project on the medical applications of medicinal mushrooms in breast cancer.
- Hifas da Terra was founded in 1998 by Catalina Fernández de Ana Portela, a biologist, mycologist and doctoral candidate in clinical oncology research at the University of Santiago de Compostela. This pioneering biotechnological project, born in Galicia, has become an international leader in the development of natural products for human health made from medicinal mushrooms.
Hifas da Terra (HdT) makes a significant contribution to research into natural products for human health with a new clinical trial on breast cancer, which is the last phase of the Microimmunomama project, led by HdT since 2019. This collaborative project, in partnership with IIS Galicia Sur (IISGS) and the technological centre Leitat, consists of studying the benefits for breast cancer patients of newly developed medicinal mushroom based nutritional supplements capable of modulating the immune response and the intestinal microbiota.
The main hypothesis of the trial is that supplementation with Mico-Mama 2.0 may improve the immune response of breast cancer patients and help regulate the gut microbiota which is altered by cancer treatments.
This randomised, double-blind, placebo-controlled clinical trial is to evaluate the efficacy and health benefits of Mico-Mama 2.0 from Hifas da Terra in breast cancer patients. Mico-Mama 2.0 will be administered once the standard oncological treatment (chemotherapy and radiotherapy) has been completed. The gut microbiota and various parameters of the immune system of these patients will be closely monitored. The trial will recruit 100-120 breast cancer patients of different subtypes (luminal A, luminal B, triple negative etc.) and will include monitoring of the gut microbiota using innovative multi-omics molecular platforms.
It is expected that the natural product, Mico-Mama 2.0, developed by HdT will also potentially reduce the side effects of primary oncology treatments, such as immunosuppression, fatigue, neurological deterioration and peripheral neuropathy, thus improving the quality of life of these patients. This study may help to define a possible future use of Mico-Mama 2.0 in the clinical management of breast cancer.
It should be noted that the first phase of the clinical study aims to define the relationship between the microbiome and breast cancer, a relationship that may have implications for the future development of diagnostic tools and/or the implementation-modulation of therapeutic interventions. Approximately 280 women will participate in this study phase, 140 patients recently diagnosed with stage I, II or III breast cancer who will receive medical oncological treatment and 140 women without breast cancer.
Mico- Mama 2.0
Modern science has discovered that medicinal mushrooms possess various active compounds with therapeutic potential, mainly anti-tumour, immunomodulatory and anti-inflammatory effects. Having spent decades studying the myriad actions of medicinal mushrooms, HdT did not hesitate to apply this data to one of the primary medical problems of the moment, breast cancer.
Mico-Mama 2.0 is a cutting-edge formula developed by Hifas da Terra with natural immunomodulatory active ingredients, such as beta-glucans, with prebiotic function, terpenes and additional prebiotics, among others.
The above-mentioned components are related to the anti-cancer properties of medicinal mushrooms. Mico-Mama 2.0 is one of the HdT Onco Care line of products, developed as a result of many years of intensive scientific research carried out in collaboration with nationally and internationally recognised institutions and organisations. These Onco Care line products contain the highest levels of active mushroom compounds ever produced compared to any other medicinal mushroom product. Each formulation combines different medicinal mushrooms with complementary and synergistic effects to provide the greatest health benefits for each type of cancer.
Breast cancer, immunity and gut microbiota
In Spain, according to data provided by the Spanish Society of Medical Oncology and the Spanish Association Against Cancer, it is estimated that one in eight women will suffer from breast cancer at some point in their lives. In 2019, it was the second most common cancer in Spain, with 33,307 new cases. This type of tumour usually appears between 35-80 years of age, with the 45-65 age bracket having the highest incidence, as this is the time when hormonal changes occur in the peri- and post-menopausal periods. The incidence curve continues to increase as women get older.
Improvements in diagnosis and treatment have increased the survival of these patients. However, breast cancer is still the tumour most frequently responsible for mortality in women today.
The current conventional forms of treatment for breast cancer are surgery, chemotherapy, radiotherapy and immunotherapy. During these treatments, immune function plays a major role in the patient’s clinical response. Any agents that can support an increase in immune function could play an important role as an adjuvant to standard treatment. After diagnosis, most patients are treated with antineoplastic therapy which results in immunosuppression. For example, chemotherapeutic myelosuppression, the decrease in bone marrow activity associated with chemotherapy that leads to an immunosuppressed and fatigued state, is one of the most serious side effects of chemotherapy. It often limits treatment duration due to low tolerability and patients require hospitalisation before full therapeutic effects can be achieved. Several studies propose that reducing myelosuppression would allow a better response to chemotherapy.
The benefits of medicinal mushroom extracts, which can be found in some nutraceuticals, have been published in several trials in cancer patients. They have been shown to improve the quality of life of these patients. Although the evidence is still limited and more clinical studies are needed, several studies suggest that mushrooms could potentially be used in the future to optimise the effect of standard cancer treatments, such as chemotherapy and radiotherapy. According to scientific evidence, immune stimulation during cancer may be beneficial in terms of tumour regression and patient survival.
In addition, immunity is closely related to the state of the gut microbiota. Studies have demonstrated that the microbiota of women with breast cancer differs from healthy women, indicating that certain bacteria may be associated with the development of cancer and responses to various treatments, such as chemotherapy. Therefore, the most recent studies suggest that alterations in the microbiota could be a new risk factor in the onset and progression of breast cancer. Thus, the role of the gut microbiota is increasingly relevant in oncology and the potentially beneficial impact of modulating it is as yet unstudied.
In recent years, it has been shown that the gut microbiota can be modulated by compounds with prebiotic activity such as those from certain medicinal mushroom species.
Based on this background, the Microinmunomama project was conceived as part of the development and functional validation of a new nutraceutical, Mico-Mama 2.0. Mico-Mamma 2.0 is formulated from medicinal mushroom extracts with the potential to affect the intestinal microbiota and stimulate the immune response, improving the progression and recovery of breast cancer patients.
Hifas da Terra, research is our foundation
Medicinal mushrooms are fascinating ‘factories’ of substances with positive effects on human health. A single species can contain hundreds of bioactive substances. According to scientific studies, medicinal mushrooms possess various anti-tumour, immunomodulatory, anti-inflammatory, antioxidant, antiviral, antibacterial, antiparasitic, hepatoprotective and anti-diabetic actions. These properties, among others, have enabled them to adapt perfectly to any environment in which they are found and to overcome any adversity without the need to become mobile.
Catalina Fernández de Ana Portela, Founder and President of Hifas da Terra, is responsible for the success of the company, founded in 1998. HdT applies expertise based on more than 20 years of research and experience, in collaboration with a large and international team of experts. HdT is a biotech company based on research and innovation, specialising in the development of nutraceuticals from medicinal mushrooms. Therefore, the objective of the research carried out by the company is the development of natural products for the maintenance and improvement of human health as adjuvants to conventional treatment or for preventive healthcare.
Hifas da Terra’s commitment to health and wellbeing translates research and innovation into the development of medicinal mushroom products such as nutraceuticals, medical devices and high quality natural medicines which can add value to the integrative care of a broad range of health conditions.
In addition to this clinical trial in breast cancer within the framework of the ‘Microimmunomama’ project, Hifas da Terra is also the leader of the homologous project called ‘Micromarker’. Another clinical trial has been launched, as part of this project, supported by the Fundación Biomédica Galicia Sur (the managing body of the IISGS), in 140 patients with colorectal cancer. Currently, HdT is also undertaking clinical research studies in a range of other areas such as gastrointestinal, immunological, musculoskeletal and mental and emotional health and diseases.
Thus, Hifas da Terra’s strong commitment to innovation, demonstrated by the reinvestment of more than 62% of our profits into research and development each year, has led to this biotech company becoming a pioneer in conducting high quality, relevant clinical trials to demonstrate the health benefits of the medicinal mushroom natural products we develop.
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