Oncologic DiseasesNUTNCT07817329
NUT Project: Nutritional Support in Thoracic Oncology
An observational study of Oncologic Diseases and Lung Cancer (NSCLC), run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
Trial summary
monitoring of the patient's nutritional status from diagnosis ensuring a dietetic-nutritional intervention throughout the treatment process Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Diseases, Lung Cancer (NSCLC)
- What is being tested?
- nutritional status
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2026to Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of advanced/metastatic non-small cell and small cell lung cancer
Who may be able to join
- Men and women aged ≥ 18 years,
- Diagnosis of advanced/metastatic non-small cell and small cell lung cancer candidates for first-line treatment of thoracic cancer
- High nutritional risk according to NRS2002 screening test (score ≥3)
- Nutritional assessment and care at the center
- Sign Informed Consent
Who cannot join
- Lack of availability of information regarding anamnestic data,
- Failure to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Elisa Roca, MD, +39 0456444193, urc@ospedalepederzoli.it
About this study
monitoring of the patient's nutritional status from diagnosis ensuring a dietetic-nutritional intervention throughout the treatment process
Read the detailed description
During the first visit, a nutritional screening test such as the Nutritional Risk Screening 2002 (NRS-2002) will be performed, which represents one of the main internationally validated screening tools (recommended by ESPEN and SINPE) for the risk of malnutrition. The test considers both the nutritional status and the degree of severity of the underlying pathology.
The final score (Total Score) is the sum of three parameters:
- Nutritional Status: Assessed by percentage of weight loss, decline in dietary income, and BMI. (Score from 0 to 3).
- Severity of the Pathology: Evaluated according to the increased metabolic requirement linked to the disease (e.g. surgery, COPD, tumors, intensive care). (Score from 0 to 3).
- Age: For patients >70 years of age, a point is added.
Based on the final score:
- patients with a score < 3 (low nutritional risk) will receive simple nutritional advice from the oncologist on the correct management of their diet during treatment.
- patients with score ≥ 3 (high nutritional risk) will be enrolled, after signing the informed consent, and subjected to a dietary - nutritional assessment as per clinical practice.
This nutritional dietary assessment is composed of:
- Use of GLIM criteria for the diagnosis of malnutrition The patient will then be assessed according to the GLIM (Global Leadership Initiative on Malnutrition) criteria, which are the international standard for the diagnosis and classification of malnutrition in adults. They are based on a two-stage process: Initial screening: Identifies the risk of malnutrition using validated tools (NRS2002 test) Diagnosis: Requires the presence of at least one phenotypic criterion and one etiological criterion. The Three Phenotypic Criteria serve to define the severity of malnutrition and are:
- Unintentional weight loss: Quantified based on the percentage of weight lost over time.
- Low Body Mass Index (BMI) based on age-specific thresholds.
- Reduced muscle mass: Assessed by body composition tests (e.g. BIA or DXA) or anthropometric measurements. The Two Etiological Criteria serve to guide the therapeutic path and are:
- Reduced food intake or absorption: Intake of a smaller amount than estimated nutritional needs.
- Inflammation or presence of pathologies: acute, chronic conditions (e.g. tumors, inflammatory diseases) or trauma that increase catabolism Based on the extent of the phenotypic criteria, it is then possible to establish the severity (stage 1 or stage 2) of malnutrition.
- Nutrition data collections
- Completion of questionnaires for data collection on health-related quality of life and oncology fatigue data (EORTC -QLQ-C30; EQ-5D-5L; FACIT-F)
This nutritional dietary assessment will be performed, in addition to the diagnosis (Time 0,) also at the following times:
- after 3-4 months i.e. at the first re-evaluation of restaging (time 1)
- after 6-8 months i.e. at the second re-evaluation of restaging (time 2)
- after 12 months i.e. at the third re-evaluation of restaging and one year after diagnosis (time 3) 3) These longitudinal reassessments will allow us to describe the impact of nutritional support on quality of life over time.
Between one evaluation and the next, patients with screening ≥ 3 taken into care, as per clinical practice, from a dietary-nutritional point of view, will receive a personalized intervention on a regular basis (approximately every 30-50 days) that can make use of counseling and/or diet therapy and/or nutritional support (use of Oral Nutritional Supplement, enteral nutrition, parenteral nutrition). The study therefore also aims to monitor the frequency and type of nutritional intervention performed (nutritional counseling and/or diet therapy and/or nutritional support) and their correlation with other variables collected as per clinical practice.
Following the enlistment phase (2 years), subjects will be observed for a total duration of 1 year at the end of which a second year is foreseen for the analysis and drafting of the results. Patients will be evaluated through a follow-up visit as per clinical practice, and those who have completed follow-up at the hospital will be contacted by telephone for a telematic data update.
- Conditions
- Oncologic Diseases, Lung Cancer (NSCLC)
- Being tested
- nutritional status
- Keywords
- nutritional support, diet, BMI, fatigue, adverse events
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional statusOther
During the first visit, a nutritional screening test such as the Nutritional Risk Screening 2002 (NRS-2002) will be performed, which represents one of the main internationally validated screening tools (recommended by ESPEN and SINPE) for the risk of malnutrition. The test considers both the nutritional status and the degree of severity of the underlying pathology.
Based on the final score:
- patients with a score < 3 will receive simple nutritional advice from the oncologist on the correct management of their diet during treatment.
- patients with score ≥ 3 will be enrolled, after signing the informed consent, and subjected to a dietary - nutritional assessment as per clinical practice.
This nutritional dietary assessment is composed of:
- Use of GLIM criteria for the diagnosis of malnutrition
- Nutrition data collections
- Completion of questionnaires for data collection on health-related quality of life and data on oncological fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of weight (kg)
Measured: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of height (cm)
Measured: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of BMI (kg/m^2)
Measured: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of fatigue (Units on a Scale)
Measured: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of adverse events
Measured: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of strength (Hand Grip)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DiseasesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817329
- Sponsor's protocol ID
- 1013CET
- Acronym
- NUT
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUT Project: Nutritional Support in Thoracic Oncology
- ClinicalTrials.gov ID
- NCT07817329
- Acronym / sponsor ID
- NUT / 1013CET
- Conditions
- Oncologic Diseases, Lung Cancer (NSCLC)
- Keywords
- nutritional support, diet, BMI, fatigue, adverse events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Sep 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.
monitoring of the patient's nutritional status from diagnosis ensuring a dietetic-nutritional intervention throughout the treatment process
Detailed description
During the first visit, a nutritional screening test such as the Nutritional Risk Screening 2002 (NRS-2002) will be performed, which represents one of the main internationally validated screening tools (recommended by ESPEN and SINPE) for the risk of malnutrition. The test considers both the nutritional status and the degree of severity of the underlying pathology.
The final score (Total Score) is the sum of three parameters:
- Nutritional Status: Assessed by percentage of weight loss, decline in dietary income, and BMI. (Score from 0 to 3).
- Severity of the Pathology: Evaluated according to the increased metabolic requirement linked to the disease (e.g. surgery, COPD, tumors, intensive care). (Score from 0 to 3).
- Age: For patients >70 years of age, a point is added.
Based on the final score:
- patients with a score < 3 (low nutritional risk) will receive simple nutritional advice from the oncologist on the correct management of their diet during treatment.
- patients with score ≥ 3 (high nutritional risk) will be enrolled, after signing the informed consent, and subjected to a dietary - nutritional assessment as per clinical practice.
This nutritional dietary assessment is composed of:
- Use of GLIM criteria for the diagnosis of malnutrition The patient will then be assessed according to the GLIM (Global Leadership Initiative on Malnutrition) criteria, which are the international standard for the diagnosis and classification of malnutrition in adults. They are based on a two-stage process: Initial screening: Identifies the risk of malnutrition using validated tools (NRS2002 test) Diagnosis: Requires the presence of at least one phenotypic criterion and one etiological criterion. The Three Phenotypic Criteria serve to define the severity of malnutrition and are:
- Unintentional weight loss: Quantified based on the percentage of weight lost over time.
- Low Body Mass Index (BMI) based on age-specific thresholds.
- Reduced muscle mass: Assessed by body composition tests (e.g. BIA or DXA) or anthropometric measurements. The Two Etiological Criteria serve to guide the therapeutic path and are:
- Reduced food intake or absorption: Intake of a smaller amount than estimated nutritional needs.
- Inflammation or presence of pathologies: acute, chronic conditions (e.g. tumors, inflammatory diseases) or trauma that increase catabolism Based on the extent of the phenotypic criteria, it is then possible to establish the severity (stage 1 or stage 2) of malnutrition.
- Nutrition data collections
- Completion of questionnaires for data collection on health-related quality of life and oncology fatigue data (EORTC -QLQ-C30; EQ-5D-5L; FACIT-F)
This nutritional dietary assessment will be performed, in addition to the diagnosis (Time 0,) also at the following times:
- after 3-4 months i.e. at the first re-evaluation of restaging (time 1)
- after 6-8 months i.e. at the second re-evaluation of restaging (time 2)
- after 12 months i.e. at the third re-evaluation of restaging and one year after diagnosis (time 3) 3) These longitudinal reassessments will allow us to describe the impact of nutritional support on quality of life over time.
Between one evaluation and the next, patients with screening ≥ 3 taken into care, as per clinical practice, from a dietary-nutritional point of view, will receive a personalized intervention on a regular basis (approximately every 30-50 days) that can make use of counseling and/or diet therapy and/or nutritional support (use of Oral Nutritional Supplement, enteral nutrition, parenteral nutrition). The study therefore also aims to monitor the frequency and type of nutritional intervention performed (nutritional counseling and/or diet therapy and/or nutritional support) and their correlation with other variables collected as per clinical practice.
Following the enlistment phase (2 years), subjects will be observed for a total duration of 1 year at the end of which a second year is foreseen for the analysis and drafting of the results. Patients will be evaluated through a follow-up visit as per clinical practice, and those who have completed follow-up at the hospital will be contacted by telephone for a telematic data update.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of advanced/metastatic non-small cell and small cell lung cancer
Key inclusion criteria (5 listed)
- Men and women aged ≥ 18 years,
- Diagnosis of advanced/metastatic non-small cell and small cell lung cancer candidates for first-line treatment of thoracic cancer
- High nutritional risk according to NRS2002 screening test (score ≥3)
- Nutritional assessment and care at the center
- Sign Informed Consent
Key exclusion criteria (2 listed)
- Lack of availability of information regarding anamnestic data,
- Failure to sign informed consent
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 |
|---|---|---|
| nutritional statusDuring the first visit, a nutritional screening test such as the Nutritional Risk Screening 2002 (NRS-2002) will be performed, which represents one of the main internationally validated screening tools (recommended by ESPEN and SINPE) for the risk of malnutrition. The test considers both the nutritional status and the degree of severity of the underlying pathology. Based on the final score: * patients with a score < 3 will receive simple nutritional advice from the oncologist on the correct management of their diet during treatment. * patients with score ≥ 3 will be enrolled, after signing the informed consent, and subjected to a dietary - nutritional assessment as per clinical practice. This nutritional dietary assessment is composed of: 1. Use of GLIM criteria for the diagnosis of malnutrition 2. Nutrition data collections 3. Completion of questionnaires for data collection on health-related quality of life and data on oncological fatigue | Other | – |
Primary outcome
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of weight (kg)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of height (cm)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of BMI (kg/m^2)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of fatigue (Units on a Scale)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of adverse events
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of strength (Hand Grip)
Time frame: through study completion, an average of 1 year
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 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Diseases and Lung Cancer (NSCLC), run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
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 5 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Elisa Roca, MD (+39 0456444193, urc@ospedalepederzoli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of weight (kg) (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. 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 14 Sep 2026.