NCT07042724 Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study
| NCT ID | NCT07042724 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita di Verona |
| Condition | Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 324 participants in total. It began in 2025-09-01 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Sara Pilotto, Ph.D., MD
PRINCIPAL INVESTIGATOR
Universita di Verona
Frequently Asked Questions
Who can join the NCT07042724 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07042724 currently recruiting?
Yes, NCT07042724 is actively recruiting participants. Contact the research team at alice.avancini@univr.it for enrollment information.
Where is the NCT07042724 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT07042724 clinical trial?
NCT07042724 is sponsored by Universita di Verona. The principal investigator is Sara Pilotto, Ph.D., MD at Universita di Verona. The trial plans to enroll 324 participants.
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