Athletic Intervention After Thoracic Surgery for Lung Cancer: Rationale and Design of the ATHENA Study.

BACKGROUND

The optimal therapeutic approach for early-stage NSCLC (I-II, and, in some specific cases, IIIa) is lung resective surgery with mediastinal lymphadenectomy. However, it should be remarked that lung resection surgery further negatively affects respiratory muscle function and health-related quality of life (HRQoL). It is well known that exercise interventions may improve pulmonary function but the optimal approach has not been determined yet.

AIMS: The aim of the present study is to investigate the results obtained by administering a specific athletic/physical protocol to a cohort of patients who undergo lung surgery after NSCLC diagnosis.

MATERIALS AND

METHODS

Among patients who underwent a surgical treatment of NSCLC and followed in our Institution, those with the highest scores of performance status, defined after multidisciplinary evaluation by Interdisciplinary Group for Thoracic Neoplasms (GINT) will be addressed to the Interdipartimental Centre in Motor and Sport Activities, Sport Medicine Centre, University of Pavia for a work protocol based on mesocycles of 3times/week for 6 months.

RESULTS

Respiratory function, cardiopulmonary exercise capacity, caloric expenditure expressed as metabolic equivalents (METs), and health-related quality of life will be assessed at baseline, 3 months, and 6 months in a prospective single-arm pilot cohort. Caloric consumption will be measured by metabolic equivalents (MET). A quality of life (QoL) questionnaire and a spirometry will be administered to patients at the same intervals.

DISCUSSION: The primary exploratory endpoint will be the change in CPET-derived VO₂peak from baseline to 6 months; secondary endpoints will include changes in FEV₁, DLCO, MIP/MEP, METs, muscle power, and EORTC QLQ-C30 scores. For each patient, written informed consent will be obtained before the enrollment.

CONCLUSION

Our study is, to the best of our knowledge the first perspective clinical trial encompassing athletic programs for patients with surgical treatment of NSCLC. The study is designed to provide preliminary data on feasibility, safety, and functional outcomes of a structured post-surgical athletic intervention in carefully selected patients with early-stage NSCLC.