Publications

Authors:

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

Title:

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

Year:

2026

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Format:

Elettronico

Referee:

Sì

Name of journal:

BMJ OPEN

ISSN of journal:

2044-6055

N° Volume:

16

Number or Folder:

1

Page numbers:

1-11

Keyword:

Exercise; Lung Neoplasms; Nutritional support; Treatment Outcome

Short description of contents:

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.

Web page:

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

Product ID:

149117

Handle IRIS:

11562/1179467

Last Modified:

January 30, 2026

Bibliographic citation:

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

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