The Effect of Chemotherapy and Surgery for Cancer on Exercise Capacity
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|ClinicalTrials.gov Identifier: NCT01325883|
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : July 12, 2016
Neoadjuvant chemotherapy (NAC) prior to surgery for upper gastrointestinal (oesophageal and gastric) cancer is associated with improved survival. The investigators propose a prospective blinded observational cohort study of patients undergoing NAC prior to elective upper gastrointestinal cancer resection (oesophagectomy and gastrectomy) in three NHS teaching hospitals. The investigators have pilot data showing that NAC reduces objectively measured exercise capacity (fitness). The literature suggests that a lower level of exercise capacity is associated with a high risk of adverse outcome (death and serious complications) after major surgery.
The investigators wish to explore the hypothesis that decrease in exercise capacity (fitness) associated with (NAC) prior to upper gastrointestinal cancer resection may outweigh the benefits (duration of survival) achieved by NAC in some patients undergoing upper gastrointestinal cancer surgery. The investigators aim to recruit 175 patients from over 36 months. Consenting patients will perform cardiopulmonary exercise testing (CPET) and complete a quality of life questionnaire prior to and 4 weeks after NAC . Postoperative outcomes measured at set time points will be objective recorded including mortality 1 year after surgery and short term postoperative harm described by the PostOperative Morbidity Survey (POMS) as well as Quality of life scores and resource use (e.g. hospital bed utilisation). Exercise capacity (fitness) before and after NAC will be assessed using CPET and the relationship between the derived variables (AT, VO2 peak) and clinical outcomes will be described.
|Condition or disease|
|Tumor of Esophagus, Stomach and Duodenum|
|Study Type :||Observational|
|Actual Enrollment :||253 participants|
|Official Title:||The Effect of Neoadjuvant Chemotherapy on Exercise Capacity and Outcome Following Upper Gastrointestinal Cancer Surgery.|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||January 2016|
- The relative decrease in exercise capacity (LT) associated with NAC prior to upper gastrointestinal cancer resection will predict outcome (1 year mortality) following surgery. [ Time Frame: three years ]
- Patients whose LT changes following NAC so that they move into a higher risk category will have a worse outcome (1 year mortality) when compared with those who do not increase risk category. [ Time Frame: 3 years ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325883
|Aintree Universty Hopsitals|
|Liverpool, United Kingdom|
|Principal Investigator:||Michael Grocott, MD FRCA FRCP||University Hospital Southampton NHS Foundation Trust|