1. Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial—the PREHAB study
- Author
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Bruno Pereira, Jean-Yves Mabrut, Marie Selvy, Johan Gagnière, Christophe Mariette, Bertrand Le Roy, Denis Pezet, Corinne Bouteloup, Frédéric Costes, Emmanuel Futier, Caroline Pétorin, Bernard Meunier, Ruddy Richard, Karem Slim, Chirurgie digestive et hépatobiliaire, Centre Hospitalier Universitaire Estaing, Unité de biostatistiques, Délégation Recherche Clinique et Innovation, Centre Hospitalier Universitaire de Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université, Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Hépatologie Gastro-Enterologie, Centre Hospitalier Universitaire (CHU), Unité de Nutrition Humaine - Clermont Auvergne (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne (UCA), Médecine du Sport et Explorations fonctionnelles, Centre Hospitalier Universitaire Gabriel Montpied, Secteur anesthésie, Chirurgie hépatobiliaire et digestive, Hôpital Pontchaillou, Chirurgie générale et digestive, Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Chirurgie générale et Digestive, Hôpital Claude Huriez, PHRC IR 2015 LE ROY, CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, CHU Clermont-Ferrand, Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université-Institut National de la Recherche Agronomique (INRA), CHU Gabriel Montpied [Clermont-Ferrand], Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille, and CHU Pontchaillou [Rennes]
- Subjects
Male ,Esophageal Neoplasms ,activité physique ,0302 clinical medicine ,Postoperative Complications ,Quality of life ,physical exercise ,Fitness ,Antineoplastic Combined Chemotherapy Protocols ,Protocol ,Prospective Studies ,prehabilitation ,gastric cancer ,fitness ,2. Zero hunger ,Cumulative dose ,recommandation alimentaire ,psychologie de la santé ,General Medicine ,dietary allowance ,Middle Aged ,adénocarcinome gastrique ,3. Good health ,adénocarcinome de l'œsophage ,Treatment Outcome ,030220 oncology & carcinogenesis ,Alimentation et Nutrition ,Adenocarcinoma ,Anxiety ,030211 gastroenterology & hepatology ,Female ,France ,Nutrition Therapy ,medicine.symptom ,medicine.medical_specialty ,Prehabilitation ,Médecine humaine et pathologie ,03 medical and health sciences ,Stomach Neoplasms ,Preoperative Care ,medicine ,Food and Nutrition ,Humans ,étude clinique ,Aged ,business.industry ,General surgery ,Gold standard ,Postoperative complication ,clinical study ,medicine.disease ,Surgery ,Quality of Life ,Human health and pathology ,Ventilatory threshold ,business ,Gastric cancer ,[SDV.AEN]Life Sciences [q-bio]/Food and Nutrition ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
Introduction 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. Methods and analysis 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 VO 2peak , 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. Ethics and dissemination 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. Trial registration number NCT02780921.
- Published
- 2016