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

Recruiting now · Not applicable

Conditions studied: Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT07042724

Run by

Universita di Verona

People needed

324

Starts

2025-09-01

Expected to finish

2030-04-30

Last updated by the study team

2025-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Verona Hospital — Verona, Italy (enrolling)

Full record on ClinicalTrials.gov

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