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The Effect of Chemotherapy and Surgery for Cancer on Exercise Capacity

NCT01325883 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 253

Last updated 2016-07-12

No results posted yet for this study

Summary

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.

Conditions

  • Tumor of Esophagus, Stomach and Duodenum

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • Liverpool University Hospitals NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Michael Grocott, MD FRCA FRCP · University Hospital Southampton NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-08-31
Completion
2016-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325883 on ClinicalTrials.gov