Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health educational material | Behavioral | — | UNRESOLVED |
| Physical exercise and nutrition for the adjuvant setting | Behavioral | — | UNRESOLVED |
| Physical exercise and nutrition intervention for the neoadjuvant setting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A - neoadiuvant setting - interventional arm
- description
- This arm will include patients undergoing neoadjuvant chemoimmunotherapy. The administered intervention will consist of a combination of exercise and nutrition support for the entire neoadjuvant treatment period.
- interventionNames
- Behavioral: Physical exercise and nutrition intervention for the neoadjuvant setting
- type
- EXPERIMENTAL
- label
- Cohort B - adiuvant setting - interventional arm
- description
- This arm will include patients undergoing adjuvant treatment as per standard of care. The administered intervention will consist of a combination of exercise and nutrition support lasting 6 months.
- interventionNames
- Behavioral: Physical exercise and nutrition for the adjuvant setting
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAvancini A, Giannarelli D, Ugel S, Mafficini A, Fiorini P, Scaglione I, Adamoli G, Borsati A, Belluomini L, Eccher S, Trestini I, Tregnago D, Sposito M, Insolda J, Schena F, Scarpa A, Derosa L, Milella M, Novello S, Pilotto S. Telehealth-delivered exercise and nutrition intervention to improve outcomes in patients with early stage non-small cell lung cancer: protocol for the multicentre STARLighT phase II (neoadjuvant) and phase III (adjuvant) trial. BMJ Open. 2026 Jan 12;16(1):e108080. doi: 10.1136/bmjopen-2025-108080. PMID 41526018