The effect of neoadjuvant chemotherapy and chemoradiotherapy on exercise capacity and outcome following upper gastrointestinal cancer surgery: an observational cohort study

BMC Cancer

Study Protocol

B. D. Dimitrov¹  S. Jack²  L. Loughney²  M. P. W. Grocott²  M. A. West³  M. G. Mythen⁴  R. Sturgess⁵  A. Kendrick⁶  P. M. A. Calverley⁷  G. Ambler⁸  J. J. Kelly⁹ 

[1] Academic Unit of Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Tremona Road, Southampton, UK;Anaesthesia and Critical Care Research Area, NIHR Respiratory Biomedical Research Unit, University Hospital Southampton NHS Foundation Trust, CE93 MP24, Tremona Road, SO16 6YD, Southampton, UK;Integrative Physiology and Critical Illness Group, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Tremona Road, Southampton, UK;Anaesthesia and Critical Care Research Area, NIHR Respiratory Biomedical Research Unit, University Hospital Southampton NHS Foundation Trust, CE93 MP24, Tremona Road, SO16 6YD, Southampton, UK;Integrative Physiology and Critical Illness Group, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Tremona Road, Southampton, UK;Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK;Centre for Anaesthesia, Institute of Sport Exercise and Health, University College London Hospitals NIHR Biomedical Research Centre, London, UK;Department of Gastroenterology, University Hospitals Aintree, Longmoor Road, Liverpool, UK;Department of Physiological Sciences, University of Bristol, Bristol, UK;Department of Respiratory Research, University of Liverpool, University Hospitals Aintree, Longmoor Road, Liverpool, UK;Department of Statistical Science, University College London, London, UK;Department of Surgery, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, UK;

关键词: Neoadjuvant;    Chemotherapy;    Chemoradiotherapy;    Cancer;    Cardiopulmonary;    Exercise test;    Fitness;    Surgery;    Outcome;    Morbidity;    Mortality;   

DOI  :  10.1186/s12885-016-2682-6

 received in 2016-01-28, accepted in 2016-08-05,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundIn 2014 approximately 21,200 patients were diagnosed with oesophageal and gastric cancer in England and Wales, of whom 37 % underwent planned curative treatments. Potentially curative surgical resection is associated with significant morbidity and mortality. For operable locally advanced disease, neoadjuvant chemotherapy (NAC) improves survival over surgery alone. However, NAC carries the risk of toxicity and is associated with a decrease in physical fitness, which may in turn influence subsequent clinical outcome. Lower levels of physical fitness are associated with worse outcome following major surgery in general and Upper Gastrointestinal Surgery (UGI) surgery in particular. Cardiopulmonary exercise testing (CPET) provides an objective assessment of physical fitness. The aim of this study is to test the hypothesis that NAC prior to upper gastrointestinal cancer surgery is associated with a decrease in physical fitness and that the magnitude of the change in physical fitness will predict mortality 1 year following surgery.MethodsThis study is a multi-centre, prospective, blinded, observational cohort study of participants with oesophageal and gastric cancer scheduled for neoadjuvant cancer treatment (chemo- and chemoradiotherapy) and surgery. The primary endpoints are physical fitness (oxygen uptake at lactate threshold measured using CPET) and 1-year mortality following surgery; secondary endpoints include post-operative morbidity (Post-Operative Morbidity Survey (POMS)) 5 days after surgery and patient related quality of life (EQ-5D-5 L).DiscussionThe principal benefits of this study, if the underlying hypothesis is correct, will be to facilitate better selection of treatments (e.g. NAC, Surgery) in patients with oesophageal or gastric cancer. It may also be possible to develop new treatments to reduce the effects of neoadjuvant cancer treatment on physical fitness. These results will contribute to the design of a large, multi-centre trial to determine whether an in-hospital exercise-training programme that increases physical fitness leads to improved overall survival.Trial registrationClinicalTrials.gov NCT01325883 - 29th March 2011.

【 授权许可】

CC BY   
© The Author(s). 2016