Lung CancerLISTENINGNCT07486947
Unveiling Malnutrition and Metabolic Changes in Lung Cancer Patients: Setting the Basis for Precision Nutrition Models.
An observational study of Lung Cancer, run by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares at 3 sites in 2 countries.
Trial summary
Malnutrition is a major cause of morbidity in a large portion of the population, particularly among people with specific medical conditions-such as lung cancer patients-and vulnerable population groups, such as pregnant women and the elderly. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Participants are not assigned an intervention as part of the study
- How many people
- 180 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Dec 2024to Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study aims to include, across the two planned recruitment centers, between 150 and 180 patients with lung cancer (non-small cell and small cell) treated with chemotherapy, immunotherapy, combinations of immunotherapy and biological therapy, patients receiving conservative therapy, without active treatment, or any other type of treatment. The recruitment centers for lung cancer patients are the Infanta Sofía University Hospital (Madrid, Spain) and the University Hospital of Parma (Parma, Italy). The recruitment center for healthy volunteers is IMDEA Nutrition.
Who may be able to join
- Study population cohort: Patients of both sexes Patients aged between 18 and 85 years Patients diagnosed with lung cancer (non-small cell and small cell) Patients treated with chemotherapy, immunotherapy, combinations of immunotherapy and biological therapy, patients receiving conservative therapy, without active treatment, or any other type of treatment, according to ESMO and NCCN guidelines for the management of metastatic lung cancer (small cell and non-small cell)
- Control population cohort: Volunteers of both sexes Volunteers aged between 18 and 85 years Volunteers free of oncological disease
Who cannot join
- Study population cohort: Patients with uncontrolled chronic diseases Patients with acute gastrointestinal diseases
- Control population cohort: Volunteers with uncontrolled chronic diseases Volunteers with acute gastrointestinal diseases Volunteers who have had any type of oncological condition at any point in their lives Volunteers with diagnosed pulmonary pathology: chronic lung disease, asthma, pulmonary fibrosis, bronchiectasis, interstitial lung disease, recent pneumonia (3-6 months), moderate/severe sleep apnea, latent or previous tuberculosis with sequelae Volunteers with underlying autoimmune diseases: rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis Volunteers with active or chronic infections: HIV, hepatitis B or C, recurrent chronic infections, tuberculosis
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Spain2 sites, 2 recruiting
- Recruiting
IMDEA Nutrition
Madrid, Madrid, 28034
Juan Moreno Rubio, +34911914164 ext. 424164, jmrubio@salud.madrid.org
- Recruiting
Infanta Sofía University Hospital
San Sebastián de los Reyes, Madrid, 28702
Juan Moreno Rubio, +34911914164 ext. 424164, jmrubio@salud.madrid.org
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Parma
Parma, Parma, 43126
Pedro Mena, +34911914164, pedromiguel.menaparreno@unipr.it
About this study
Official title: LISTENING: Unveiling Malnutrition and Metabolic Changes in Lung Cancer Patients: Setting the Basis for Precision Nutrition Models. The Listenig Nutritional Study is Part of the Project MENTORING (Project ID: 101162297; Call: HORIZON-EIC-2023-PATHFINDERCHALLENGES-01; Programme: HORIZON; DG/Agency: EISMEA; Title: Addressing Malnutrition and Metabolic Health in Non-communicable Diseases Through Precision Nutrition: Impact in Quality of Life and Prognosis of Lung Cancer Patients)
Malnutrition is a major cause of morbidity in a large portion of the population, particularly among people with specific medical conditions-such as lung cancer patients-and vulnerable population groups, such as pregnant women and the elderly. Lung cancer represents one of the most significant health problems in today's society, with an incidence of 1.8 million cases per year (13% of all cancer cases) and an estimated mortality of 1.6 million deaths annually, making it the leading cause of cancer-related death worldwide.
The aim of this study is to collect data from different lung cancer patients in order to establish a precision nutrition recommendation model. The model will be capable of comprehensively characterizing the nutritional and metabolic status of individuals with nutritional impairment and, therefore, provide personalized dietary solutions based on the unique characteristics of each individual.
Read more
To date, the number of personalized nutritional approaches to address malnutrition is relatively small; they have only been applied in very specific cases and generally have not addressed nutritional deficiencies as a whole but rather individual deficiencies. Additionally, these initiatives focused more on stratified nutrition (for groups of individuals) rather than precision nutrition (for individual persons), and in almost no case were factors such as genetics and the microbiome-key components of personalized nutrition-taken into account. This highlights the need to generate precision nutrition models that are capable of addressing the complexity of each individual and providing unique solutions for each nutritional and metabolic state. Despite the interest in these initiatives, no precise dietary personalization that considers the singularities of patients has been carried out to date.
The proposed intervention is a prospective study whose main objective is to collect data for the proper and precise characterization of malnutrition status in lung cancer patients and to evaluate the role of major factors related to metabolic health (composition and functionality of genotype and gut microbiota, among others) and the pathogenesis and progression of cancer (tumor characterization, composition and functionality of the lung microbiota, etc.) on the nutritional status, quality of life, and prognosis of these patients. This nutritional study is therefore an exploratory initiative that takes into account several factors contributing to the nutritional and health status of malnourished individuals.
The study will be conducted within the framework of the MENTORINNG project (Project ID: 101162297; Title: Addressing malnutrition and metabolic health in non-communicable diseases through precision Nutrition: impact on quality of life and prognosis of lung cancer patients). Under this umbrella, a multidisciplinary consortium has been created and funded under the "HORIZON-EIC-2023-PATHFINDERCHALLENGES-01; Programme: HORIZON; DG/Agency: EISMEA" call, with a budget of €4,031,666.25 for the development of scientific activities. Several international institutions are part of this consortium.
- Conditions
- Lung Cancer
- Being tested
- Participants are not assigned an intervention as part of the study
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants are not assigned an intervention as part of the studyOther
Participants are not assigned an intervention as part of the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection
Data collection for analysis and later use regarding the malnutrition status of lung cancer patients, taking into account both body composition and nutrient biomarkers.
Measured: From registration until 6 months have passed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start15 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486947
- Sponsor's protocol ID
- PI-068
- Acronym
- LISTENING
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LISTENING: Unveiling Malnutrition and Metabolic Changes in Lung Cancer Patients: Setting the Basis for Precision Nutrition Models. The Listenig Nutritional Study is Part of the Project MENTORING (Project ID: 101162297; Call: HORIZON-EIC-2023-PATHFINDERCHALLENGES-01; Programme: HORIZON; DG/Agency: EISMEA; Title: Addressing Malnutrition and Metabolic Health in Non-communicable Diseases Through Precision Nutrition: Impact in Quality of Life and Prognosis of Lung Cancer Patients)
- ClinicalTrials.gov ID
- NCT07486947
- Acronym / sponsor ID
- LISTENING / PI-068
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-HenaresUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malnutrition is a major cause of morbidity in a large portion of the population, particularly among people with specific medical conditions-such as lung cancer patients-and vulnerable population groups, such as pregnant women and the elderly. Lung cancer represents one of the most significant health problems in today's society, with an incidence of 1.8 million cases per year (13% of all cancer cases) and an estimated mortality of 1.6 million deaths annually, making it the leading cause of cancer-related death worldwide.
The aim of this study is to collect data from different lung cancer patients in order to establish a precision nutrition recommendation model. The model will be capable of comprehensively characterizing the nutritional and metabolic status of individuals with nutritional impairment and, therefore, provide personalized dietary solutions based on the unique characteristics of each individual.
To date, the number of personalized nutritional approaches to address malnutrition is relatively small; they have only been applied in very specific cases and generally have not addressed nutritional deficiencies as a whole but rather individual deficiencies. Additionally, these initiatives focused more on stratified nutrition (for groups of individuals) rather than precision nutrition (for individual persons), and in almost no case were factors such as genetics and the microbiome-key components of personalized nutrition-taken into account. This highlights the need to generate precision nutrition models that are capable of addressing the complexity of each individual and providing unique solutions for each nutritional and metabolic state. Despite the interest in these initiatives, no precise dietary personalization that considers the singularities of patients has been carried out to date.
The proposed intervention is a prospective study whose main objective is to collect data for the proper and precise characterization of malnutrition status in lung cancer patients and to evaluate the role of major factors related to metabolic health (composition and functionality of genotype and gut microbiota, among others) and the pathogenesis and progression of cancer (tumor characterization, composition and functionality of the lung microbiota, etc.) on the nutritional status, quality of life, and prognosis of these patients. This nutritional study is therefore an exploratory initiative that takes into account several factors contributing to the nutritional and health status of malnourished individuals.
The study will be conducted within the framework of the MENTORINNG project (Project ID: 101162297; Title: Addressing malnutrition and metabolic health in non-communicable diseases through precision Nutrition: impact on quality of life and prognosis of lung cancer patients). Under this umbrella, a multidisciplinary consortium has been created and funded under the "HORIZON-EIC-2023-PATHFINDERCHALLENGES-01; Programme: HORIZON; DG/Agency: EISMEA" call, with a budget of €4,031,666.25 for the development of scientific activities. Several international institutions are part of this consortium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to include, across the two planned recruitment centers, between 150 and 180 patients with lung cancer (non-small cell and small cell) treated with chemotherapy, immunotherapy, combinations of immunotherapy and biological therapy, patients receiving conservative therapy, without active treatment, or any other type of treatment. The recruitment centers for lung cancer patients are the Infanta Sofía University Hospital (Madrid, Spain) and the University Hospital of Parma (Parma, Italy). The recruitment center for healthy volunteers is IMDEA Nutrition.
Key inclusion criteria (2 listed)
- Study population cohort: Patients of both sexes Patients aged between 18 and 85 years Patients diagnosed with lung cancer (non-small cell and small cell) Patients treated with chemotherapy, immunotherapy, combinations of immunotherapy and biological therapy, patients receiving conservative therapy, without active treatment, or any other type of treatment, according to ESMO and NCCN guidelines for the management of metastatic lung cancer (small cell and non-small cell)
- Control population cohort: Volunteers of both sexes Volunteers aged between 18 and 85 years Volunteers free of oncological disease
Key exclusion criteria (2 listed)
- Study population cohort: Patients with uncontrolled chronic diseases Patients with acute gastrointestinal diseases
- Control population cohort: Volunteers with uncontrolled chronic diseases Volunteers with acute gastrointestinal diseases Volunteers who have had any type of oncological condition at any point in their lives Volunteers with diagnosed pulmonary pathology: chronic lung disease, asthma, pulmonary fibrosis, bronchiectasis, interstitial lung disease, recent pneumonia (3-6 months), moderate/severe sleep apnea, latent or previous tuberculosis with sequelae Volunteers with underlying autoimmune diseases: rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis Volunteers with active or chronic infections: HIV, hepatitis B or C, recurrent chronic infections, tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants are not assigned an intervention as part of the studyParticipants are not assigned an intervention as part of the study | Other | – |
Primary outcome
Data collection
Time frame: From registration until 6 months have passed.
Data collection for analysis and later use regarding the malnutrition status of lung cancer patients, taking into account both body composition and nutrient biomarkers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Moreno Rubio (+34911914164 ext. 424164, jmrubio@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection (time frame: From registration until 6 months have passed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.