Pubblicazioni

Autori:

Avancini, Alice; Giannarelli, Diana; Ugel, Stefano; Mafficini, Andrea; Fiorini, Paolo; Scaglione, Ilaria; Adamoli, Gloria; Borsati, Anita; Belluomini, Lorenzo; Eccher, Serena; Trestini, Ilaria; Tregnago, Daniela; Sposito, Marco; Insolda, Jessica; Schena, Federico; Scarpa, Aldo; Derosa, Lisa; Milella, Michele; Novello, Silvia; Pilotto, Sara

Titolo:

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

Anno:

2026

Tipologia prodotto:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Lingua:

Inglese

Formato:

Elettronico

Referee:

Sì

Nome rivista:

BMJ OPEN

ISSN Rivista:

2044-6055

N° Volume:

16

Numero o Fascicolo:

1

Intervallo pagine:

1-11

Parole chiave:

Exercise; Lung Neoplasms; Nutritional support; Treatment Outcome

Breve descrizione dei contenuti:

Introduction: In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC. Methods and analysis: STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB-IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune-inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations. Ethics and dissemination: The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates. Trial registration number: Clinicaltrial.gov: NCT07042724.

Pagina Web:

https://doi.org/10.1136/bmjopen-2025-108080

Id prodotto:

149117

Handle IRIS:

11562/1179467

ultima modifica:

30 gennaio 2026

Citazione bibliografica:

Avancini, Alice; Giannarelli, Diana; Ugel, Stefano; Mafficini, Andrea; Fiorini, Paolo; Scaglione, Ilaria; Adamoli, Gloria; Borsati, Anita; Belluomini, Lorenzo; Eccher, Serena; Trestini, Ilaria; Tregnago, Daniela; Sposito, Marco; Insolda, Jessica; Schena, Federico; Scarpa, Aldo; Derosa, Lisa; Milella, Michele; Novello, Silvia; Pilotto, Sara, 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» , vol. 16 , n. 1 , 2026 , pp. 1-11

Consulta la scheda completa presente nel repository istituzionale della Ricerca di Ateneo