Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study
Recruiting · NCT07042724 · Interventional (participants receive a specific treatment) · Lead sponsor: Universita di Verona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Verona Hospital - Verona, Italy