Structured exercise and nutrition program for people with early-stage non-small cell lung cancer
PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study
This trial tests whether a structured exercise and nutrition program can improve treatment response and disease-free survival for people with early-stage non-small cell lung cancer receiving neoadjuvant or adjuvant therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Locations | 1 site (Verona) |
| Trial ID | NCT07042724 on ClinicalTrials.gov |
What this trial studies
STARLighT enrolls two cohorts of patients with resectable or resected EGFR/ALK wild-type NSCLC (stage IB–IIIB): one cohort undergoing neoadjuvant therapy and one undergoing adjuvant therapy. Participants receive a structured physical exercise and nutritional program throughout their anticancer treatment, plus health education materials and a monitoring device, while comparators receive usual care. Key outcomes include pathological complete response in the neoadjuvant cohort and disease-free survival in the adjuvant cohort, with additional measures of fitness, nutritional status, and treatment tolerability. The trial is single-center at Verona Hospital and requires participants to have ECOG 0–1 and provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with resectable or resected non–oncogene-addicted NSCLC (stage IB–IIIB), ECOG performance status 0–1, who are scheduled for or receiving neoadjuvant or adjuvant systemic therapy and are willing to use the study's monitoring device.
Not a fit: Patients with absolute contraindications to exercise (for example unstable cardiac disease or uncontrolled hypertension), those requiring artificial nutrition, with severely reduced mobility, severe organ dysfunction, or tumors with targetable oncogene alterations are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase rates of complete tumor response, extend disease-free survival, and improve patients' physical fitness and nutritional status during treatment.
How similar studies have performed: Previous cancer rehabilitation studies have shown that exercise and nutritional support can improve fitness, reduce complications, and enhance quality of life, but evidence that they specifically increase pathological complete response or disease-free survival in early-stage NSCLC is limited, making this application relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Verona
- Verona Hospital — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Sara Pilotto, Ph.D., MD — Universita di Verona
- Study coordinator: Alice Avancini, Ph.D.
- Email: alice.avancini@univr.it
- Phone: +39 3403624264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.