CNIO Building / Laura M. Lombardía. CNIO
The trial will take place at 12 de Octubre Hospital and will recruit patients with breast or gynaecological tumours treated with ADCs, antibody-drug conjugates
This is one of the first clinical trials on dietary intervention and cancer, designed to optimise treatments
The trial, called LUMINOVA, is a collaboration between CNIO, 12 de Octubre Hospital, Carlos III University and two companies: TNC and eB2
The LUMINOVA clinical trial has just started, aiming to observe the effect of a personalised diet on the metabolism, microbiome and quality of life of patients with metastatic breast or gynaecological cancer, as well as on the effectiveness of the treatment. The work will also analyse differences in the results. The trial is recruiting only patients treated with antibody-drug conjugates (ADCs), a type of cutting-edge therapy that delivers small doses of concentrated chemotherapy.
Nutrition has traditionally been considered a way to support disease prevention, but it could also be a tool capable of influencing treatment. According to Miguel Ángel Quintela, head of the Breast Cancer Clinical Research Unit at the Spanish National Cancer Research Centre (CNIO), “there is evidence that the effectiveness of cancer therapies can be influenced by factors such as exercise, emotional state or diet”.
Luis Manso, an oncologist at 12 de Octubre Hospital and the i+12 Breast and Gynaecological Cancer Group, points out that LUMINOVA is “one of the first studies approaching personalised nutrition not as a supplement, but as an active intervention in patients with advanced cancer who are undergoing state-of-the-art therapies.”
With the clinical data of each patient, an algorithm will generate guidelines on their need for certain micro and macronutrients. This algorithm, called LUMICA, has been developed based on existing scientific understanding of the relationship between nutrition, cancer and numerous factors that vary in each patient: the type of tumour mutations, metabolic aberrations, interventions that have demonstrated preclinical or clinical efficacy, alterations of the microbiome… The LUMICA algorithm integrates this knowledge and proposes the most suitable dietary guidelines for each patient.
About the trial
The trial will randomly create two groups of patients: a control group, which will follow a Mediterranean diet, and an experimental group, which will follow a personalised diet. A nutritionist will design the personalised diet based on the guidelines generated by the algorithm, taking into account individual preferences and possible needs due to other health conditions. That diet can be adjusted over time. Each participant will remain in the trial voluntarily until it is necessary to modify the treatment due to illness progression.
Participants will be monitored through regular testing, devices that will collect parameters such as blood sugar levels, physical activity, circadian rhythm and sleep quality, as well as an application that will record the nutrients ingested through photographs of meals, as well as symptoms and perceived stress levels.
This methodology aims to mitigate the factors that have so far limited studies on diets: the difficulty of monitoring whether the diet is being followed; and the problem of distinguishing whether the effects achieved are due to the change in the diet or to individual characteristics of each patient.
The trial applies “AI tools, metabolomics and advanced image analysis, along with a reminder system to partially alleviate these limitations. This way, we can take advantage of what new technologies offer to make sure we are following the right methodology for this kind of trial,” states Quintela.
Luis Manso adds: “The study opens up new perspectives for precision oncology, going beyond just considering the tumour and drugs, as it incorporates the metabolism, microbiota and the individual biological environment of each patient. It integrates quality of life, emotional health and perceived toxicity as its main objectives.”
The institutions participating in LUMINOVA will be responsible for the following functions, although they will overlap to some extent:
- 12 de Octubre Hospital recruits and treats the patients; CNIO performs the analysis of microbiomes, metabolism, pharmacodynamics and data; Madrid’s Carlos III University carries out digital phenotyping and also analyses data; eB2 designs and maintains the application used by the patients; and TNC Therapy designs the patients’ diets.
- TNC is a CNIO spin off company, co-founded by Miguel Ángel Quintela, Luis Manso and José Carlos Quintela.
- eB2 is a UC3M spin off company, co-founded by Antonio Artés and Ana Hernando, among others, specialised in patient monitoring.
Funding
This trial receives financial support through the RETOS programme for public-private collaboration, part of Spain’s State Research Agency, affiliated to the Department of Science, Innovation and Universities.
About the National Cancer Research Centre (CNIO)
The National Cancer Research Centre (CNIO) is a public research centre under the Department of Science, Innovation and Universities. It is the largest cancer research centre in Spain and one of the most important in Europe. It includes around five hundred scientists, along with support staff, who are working to improve the prevention, diagnosis and treatment of cancer.