{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:38:46Z","timestamp":1792798726365,"version":"4.5.0"},"reference-count":35,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T00:00:00Z","timestamp":1768176000000},"content-version":"unspecified","delay-in-days":11,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Associazione Italiana per la Ricerca sul Cancro (AIRC","award":["30204"],"award-info":[{"award-number":["30204"]}],"id":[{"id":"https:\/\/ror.org\/02g2x7380","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,12,4]]},"published-print":{"date-parts":[[2026,1]]},"abstract":"\n Introduction<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n \n STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB\u2013IIIA)\n epidermal growth factor receptor<\/jats:italic>\n and\n anaplastic lymphoma kinase<\/jats:italic>\n 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\u2013inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.\n <\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n \n The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (\n NCT07042724<\/jats:ext-link>\n ). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.\n <\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n Clinicaltrial.gov:\n NCT07042724<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-108080","type":"journal-article","created":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T15:30:48Z","timestamp":1768231848000},"page":"e108080","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"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"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct07042724","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct07042724","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct07042724","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Alice","family":"Avancini","sequence":"first","affiliation":[{"name":"Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy"},{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Giannarelli","sequence":"additional","affiliation":[{"name":"Facility of Epidemiology and Biostatistics, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Ugel","sequence":"additional","affiliation":[{"name":"Immunology Section, University of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Mafficini","sequence":"additional","affiliation":[{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"},{"name":"ARC-Net Research Centre, University of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Fiorini","sequence":"additional","affiliation":[{"name":"Department of Engineering for Innovation Medicine, University of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilaria","family":"Scaglione","sequence":"additional","affiliation":[{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gloria","family":"Adamoli","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy"},{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Borsati","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy"},{"name":"Biomedical, Clinical and Experimental Sciences, University of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1981-5499","authenticated-orcid":false,"given":"Lorenzo","family":"Belluomini","sequence":"additional","affiliation":[{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serena","family":"Eccher","sequence":"additional","affiliation":[{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilaria","family":"Trestini","sequence":"additional","affiliation":[{"name":"Dietetic Service, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Tregnago","sequence":"additional","affiliation":[{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Sposito","sequence":"additional","affiliation":[{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Insolda","sequence":"additional","affiliation":[{"name":"Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, and University and Hospital Trust (AOUI) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Schena","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aldo","family":"Scarpa","sequence":"additional","affiliation":[{"name":"Section of Pathology, Department of Diagnostics and Public Health; 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