Background: Surgery is the only potentially curative treatment for gastric cancer, however, it bears a high postoperative morbidity and mortality rate. A recent randomized control trial proposed prehabilitation to reduce the postoperative morbidity in patients undergoing major abdominal surgery. Currently, there is a lack of evidence of using prehabilitation for patients undergoing gastrectomy for gastric cancer. The aim of our study is to demonstrate that home-based prehabilitation can reduce postoperative morbidity after gastrectomy for gastric cancer.
Methods: PREFOG is a multi-center, open-label randomized control trial comparing 90-days postoperative morbidity rate after gastrectomy for gastric cancer between patients with or without prehabilitation. One-hundred twenty-eight patients will be randomized into an intervention or control group. The intervention arm will receive trimodal home-based prehabilitation including nutritional, psychological and exercise interventions. Secondary outcomes of the study will include physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board.
Discussion: PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer. Moreover, this study will allow us to determine whether prehabilitation can improve physical fitness and activity levels, nutritional status and quality of life as well as reducing anxiety and depression levels after gastrectomy for gastric cancer.
Trial registration: ClinicalTrials.gov NCT04223401 (First posted: 10 January 2020).