NCT07042724Recruiting
Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study
PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 324 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Apr 2030
- Lead sponsor
- Universita di Verona
- Diseases
- Lung cancer
- NCT number
- NCT07042724
What you commit to
- Study type: Interventional
- Planned participants: 324
- From 1 Sept 2025 to the primary completion date, 30 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- evidence in the medical record of absolute contraindications to exercise, nutritional, or psychological intervention \[i.e., heart insufficiency; uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction, bone marrow insufficiency); reduced standing or walking ability; myocardial infarction\].
Other
- indications for or ongoing artificial nutrition support (totally compromised spontaneous food intake).
- incapacity, or unavailability to consume oral nutritional supplements.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Verona Hospital Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.