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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

    Peschiera del Garda, Verona, 37019

    Elisa Roca, MD, +39 0456444193, urc@ospedalepederzoli.it

    Recruiting

Other trials in Italy

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:

  1. Nutritional Status: Assessed by percentage of weight loss, decline in dietary income, and BMI. (Score from 0 to 3).
  2. 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).
  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:

  1. 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.
  1. Nutrition data collections
  2. 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.

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:

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted14 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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)
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

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.

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