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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.
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.
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.
Clinicaltrial.gov: NCT07042724.
by Roberto Germano, Owen Alexander Higgins, Emanuela Cristiani, Alessia Galbusera, Carmen Esposito, Dulce Neves, Carmine Pellegrino, Alessandra Sperduti, Giorgio Manzi, Luca Bondioli, Alessia Nava
This study investigates health, dental development, diet, and human-environment interactions in individuals buried in the necropolises of Pontecagnano (Campania, Italy, 7th-6th century BCE), using an integrated approach merging dental histomorphometry and calculus micro-residue analysis. The sample consists of 30 permanent teeth (canines, first and second molars) from 10 individuals. Histomorphometric analysis of dental thin sections allowed the estimation of crown formation times, initial cusp formation, crown completion, and enamel extension rates. The prevalence of Accentuated Lines, marking physiological stress events, was analyzed chronologically across tooth classes. Dental calculus analysis was performed on five individuals, identifying plant micro-remains and fungal spores. Crown formation times varied by tooth class, with canines forming the longest (mean = 1,977 ± 295 days), followed by second molars (mean = 1,176 ± 179 days) and first molars (mean = 1,094 ± 154 days). Initial cusp formation values, estimated through chronological overlap between teeth, allowed for a more accurate reconstruction of crown completion timing. Accentuated Lines prevalence peaked at 12 and 44 months, likely reflecting early childhood dietary transitions and the differential recording of stress events across different crown regions. Calculus analysis identified starch granules from cereals (Triticeae) and legumes (Fabaceae), fungal spores (Saccharomyces), and plant fibers, indicating diverse dietary practices, food processing, and extra-masticatory activities. This interdisciplinary approach reinforces the validity of combining histomorphometric and micro-residue analyses to reconstruct childhood health, adult diet, and lifestyle. Our findings align with previous research while emphasizing population-specific variations. This study enhances understanding of Iron Age biocultural adaptations, offering insights into developmental and dietary behaviors in this ancient Italian community.
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