Effects of exercise and diet in patients with incurable gastroesophageal cancer: the RADICES study

Abstract

Background Patients with incurable gastroesophageal adenocarcinoma have an impaired health-related quality of life (HRQOL). Exercise combined with nutritional support may improve this outcome. Careful evaluation of this supportive care strategy is needed to avoid burdening patients at this vulnerable stage with interventions that may offer no (meaningful) benefit. Therefore, this study aims to investigate the effects of a combined exercise and nutritional intervention on HRQOL in patients with incurable gastroesophageal adenocarcinoma. Methods RADICES (the effect of exeRcise And Diet on quality of life in patients with Incurable Cancer of Esophagus and Stomach) is a multicenter randomized controlled trial aiming to include 196 patients with incurable gastroesophageal adenocarcinoma. Participants are randomly assigned (1:1) to a patient-tailored intervention or a control group. The intervention group is provided with 2 training sessions per week and biweekly nutritional consultations, delivered by trained physiotherapists and dietitians, during 12 weeks. The control group receives usual care supplemented with general physical activity advice. The primary outcome is the difference in HRQOL between the intervention group and the control group at 12 weeks, accounting for baseline HRQOL, measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–30 summary score. HRQOL is assessed at baseline, 6 weeks, 12 weeks, and every 3 months thereafter up to 1 year. Key secondary outcomes include patient-reported outcomes, cardiorespiratory fitness, dietary intake, disease progression, overall survival, and cost-effectiveness. Adherence and safety are monitored throughout the intervention period. Conclusion This study will generate evidence on the effectiveness of a patient-tailored combined exercise and nutritional intervention in patients with incurable gastroesophageal adenocarcinoma. If effective for HRQOL, this intervention could be integrated into standard care for patients with incurable gastroesophageal adenocarcinoma. Trial registration clinicaltrials.gov NCT06138223. Date of trial registration: November 18, 2023 Date and version study protocol: 28-04-2025 version 3.1