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Trial record 1 of 1 for:    NCT01325883
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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
Sponsor:
Collaborator:
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
Michelle Mossa, Liverpool University Hospitals NHS Foundation Trust

Brief 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.


Condition or disease
Tumor of Esophagus, Stomach and Duodenum

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Study Type : Observational
Actual Enrollment : 253 participants
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a multicentre study the recruitment will be from all the 3 centres included in the study proposal
Criteria

Inclusion Criteria:

  • all patients listed to undergo elective upper gastrointestinal cancer resection (oesophagectomy and gastrectomy) and NAC in the three NHS teaching hospitals (Bristol Royal infirmary, Aintree University Hospitals NHS Foundation Trust (and Liverpool University Hospitals), Southampton General Hospital).

Exclusion Criteria:

  • Unable to consent. Under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325883


Locations
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United Kingdom
Aintree Universty Hopsitals
Liverpool, United Kingdom
Sponsors and Collaborators
Liverpool University Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Investigators
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Principal Investigator: Michael Grocott, MD FRCA FRCP University Hospital Southampton NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michelle Mossa, Director of Research and Development, Liverpool University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01325883    
Other Study ID Numbers: 10/WMW01/15
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases