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NCT07042724 | RECRUITING | Lung Cancer (NSCLC)

Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study
Sponsor:

University of Verona

Information provided by (Responsible Party):

Sara Pilotto

Brief Summary:

The general goal of the STARLighT study is to test whether a structured physical exercise and nutritional intervention significantly impacts clinical outcomes in patients with early-stage lung cancer. The main questions it aims to answer are: * Can structured physical exercise and nutrition intervention positively modify the pathological complete response in patients with early-stage lung cancer undergoing neoadjuvant treatments? * Can structured physical exercise and nutrition intervention positively influence disease-free survival in patients with early-stage lung cancer undergoing adjuvant treatments compared to usual care? This study will recruit two cohorts of patients. Cohort A will accrue patients who are candidates for neoadjuvant treatment and offer the opportunity to participate in a structured physical exercise and nutritional program, lasting the entire period of anticancer treatment. Cohort B will accrue patients who are candidates for adjuvant treatments. Patients will be randomized to receive 6 months of structured physical exercise and nutritional intervention or standard of care.

Condition or disease

Lung Cancer (NSCLC)

Intervention/treatment

Physical exercise and nutrition intervention for the neoadjuvant setting

Physical exercise and nutrition for the adjuvant setting

Health educational material

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 324 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2030-04-30
Estimated Study Completion Date : 2030-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion criteria
  • * age ≥ 18 years.
  • * confirmed diagnosis of resectable or resected non-oncogene addicted NSCLC (EGFR, ALK wild-type).
  • * stage IB to IIIB.
  • * candidate or undergoing systemic treatment.
  • * ECOG performance status 0-1.
  • * written informed consent.
  • * willingness to use the technology/device specifically developed for patients' monitoring and support within the trial.
  • Exclusion criteria
  • * evidence in the medical record of absolute contraindications to exercise, nutritional, or psychological intervention \[i.e., heart insufficiency; uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction, bone marrow insufficiency); reduced standing or walking ability; myocardial infarction\].
  • * indications for or ongoing artificial nutrition support (totally compromised spontaneous food intake).
  • * incapacity, or unavailability to consume oral nutritional supplements.
    • Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study

    Location Details

    NCT07042724

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    Italy,

    Verona Hospital

    Verona, Italy, 37131