title: Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial-the PREHAB study.
abstract: Perioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment.
  
  
  
  The PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received.
  
  
  
  The study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal.
  
  
  
  NCT02780921.
authors.affiliation: Digestive Surgery and Oncological Department, Hospital Estaing, Clermont-Ferrand, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Le Roy
authors.affiliation: Biostatistics unit (DRCI), Clermont-Ferrand University Hospital, Clermont-Ferrand, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.affiliation: Digestive and Liver Disease Unit, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.|Human Nutrition Unit, Clermont Auvergne University, University of Auvergne, Clermont-Ferrand, France.|INRA, UMR 1019, UNH, CRNH Auvergne, Clermont-Ferrand, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Bouteloup
authors.affiliation: INRA, UMR 1019, UNH, CRNH Auvergne, Clermont-Ferrand, France.|Department of Sports Medicine and Functional Explorations, Hospital, Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Costes
authors.affiliation: INRA, UMR 1019, UNH, CRNH Auvergne, Clermont-Ferrand, France.|Department of Sports Medicine and Functional Explorations, Hospital, Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Ruddy
authors.initials: R
authors.lastname: Richard
authors.affiliation: Digestive Surgery and Oncological Department, Hospital Estaing, Clermont-Ferrand, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Selvy
authors.affiliation: Digestive Surgery and Oncological Department, Hospital Estaing, Clermont-Ferrand, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Pétorin
authors.affiliation: Digestive Surgery and Oncological Department, Hospital Estaing, Clermont-Ferrand, France.
authors.forename: Johan
authors.initials: J
authors.lastname: Gagnière
authors.affiliation: Department of Anesthesia, Hospital Estaing, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Futier
authors.affiliation: Digestive Surgery and Oncological Department, Hospital Estaing, Clermont-Ferrand, France.
authors.forename: Karem
authors.initials: K
authors.lastname: Slim
authors.affiliation: Digestive Surgery Department, Hospital Pontchaillou, Rennes, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Meunier
authors.affiliation: Digestive Surgery Department, Hospital Croix Rousse, Lyon, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mabrut
authors.affiliation: Department of Digestive and Oncological Surgery, Hospital Claude Huriez, Lille, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Mariette
authors.affiliation: Digestive Surgery and Oncological Department, Hospital Estaing, Clermont-Ferrand, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Pezet
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D004938:Esophageal Neoplasms / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D044623:Nutrition Therapy; D011183:Postoperative Complications / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome
keywords: Fitness; Gastric cancer; Prehabilitation