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

RecruitingNAAges 18 Years - anyAllUniversita di Verona
NCT07042724 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 anticance

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📋 Eligibility rules (as published)
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.
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What it tests

  • Physical exercise and nutrition intervention for the neoadjuvant setting
  • Physical exercise and nutrition for the adjuvant setting
  • Health educational material
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Where

1 site
Verona Hospital
Verona, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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