{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy",
        "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": "Alice Avancini"
    },
    {
      "affiliations": [
        "Facility of Epidemiology and Biostatistics, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy"
      ],
      "name": "Diana Giannarelli"
    },
    {
      "affiliations": [
        "Immunology Section, University of Verona, Verona, Italy"
      ],
      "name": "Stefano Ugel"
    },
    {
      "affiliations": [
        "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",
        "ARC-Net Research Centre, University of Verona, Verona, Italy"
      ],
      "name": "Andrea Mafficini"
    },
    {
      "affiliations": [
        "Department of Engineering for Innovation Medicine, University of Verona, Verona, Italy"
      ],
      "name": "Paolo Fiorini"
    },
    {
      "affiliations": [
        "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": "Ilaria Scaglione"
    },
    {
      "affiliations": [
        "Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy",
        "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": "Gloria Adamoli"
    },
    {
      "affiliations": [
        "Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy",
        "Biomedical, Clinical and Experimental Sciences, University of Verona, Verona, Italy"
      ],
      "name": "Anita Borsati"
    },
    {
      "affiliations": [
        "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": "Lorenzo Belluomini"
    },
    {
      "affiliations": [
        "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": "Serena Eccher"
    },
    {
      "affiliations": [
        "Dietetic Service, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy"
      ],
      "name": "Ilaria Trestini"
    },
    {
      "affiliations": [
        "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": "Daniela Tregnago"
    },
    {
      "affiliations": [
        "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": "Marco Sposito"
    },
    {
      "affiliations": [
        "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": "Jessica Insolda"
    },
    {
      "affiliations": [
        "Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy"
      ],
      "name": "Federico Schena"
    },
    {
      "affiliations": [
        "Section of Pathology, Department of Diagnostics and Public Health",
        "ARC-Net Research Centre, University of Verona, Verona, Italy"
      ],
      "name": "Aldo Scarpa"
    },
    {
      "affiliations": [
        "Gustave Roussy Cancer Campus (GRCC), Clinicobiome, Gustave Roussy, Villejuif Cedex, France",
        "Faculté de Medicine, Université Paris-Saclay, Ile-de-France, France",
        "Equipe Labellisée-Ligue Nationale contre le Cancer, Institut National de la Santé et de la Recherche Médicale (INSERM) U1015, Villejuif, France",
        "Department of Clinical Oncology, Gustave Roussy, Villejuif, France"
      ],
      "name": "Lisa Derosa"
    },
    {
      "affiliations": [
        "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": "Michele Milella"
    },
    {
      "affiliations": [
        "Department of Oncology, University of Turin, Orbassano, Turin, Italy"
      ],
      "name": "Silvia Novello"
    },
    {
      "affiliations": [
        "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": "Sara Pilotto"
    }
  ],
  "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",
  "uid": "7a2ac7c7-c1d4-5999-a302-fa402cfe77d3"
}