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Clinical Trials/NCT00833508
NCT00833508
Completed
Not Applicable

Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing

Imperial College London1 site in 1 country40 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Imperial College London
Enrollment
40
Locations
1
Primary Endpoint
Change of Anaerobic threshold of 1.5ml/min/kg or more
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.

Detailed Description

Chemoradiotherapy is associated with adverse effects. Patients with certain colorectal cancers undergo chemoradiotherapy prior to surgical resection. We intend to assess patient exercise capacity before and after chemoradiotherapy to assess whether this deteriorates. If there is a deleterious effect, this may affect operative outcome.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
October 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age greater than 65
  • Colorectal cancer requiring preoperative chemoradiotherapy

Exclusion Criteria

  • Inability to walk, or exercise on a bicycle or treadmill
  • Inability to understand instructions for CPET testing
  • ASA grade 4 or 5 (indicating severe cardiovascular co-morbidity and not expected to survive surgery)
  • Contraindications to Exercise Testing
  • Myocardial infarction occurring 10 days or less before CPX testing
  • Symptomatic arrythmias
  • Left Main Stem coronary disease of \>50%
  • Severe hypertension (SBP\>180mmHg)
  • Resting SpO2 \<85%
  • Acute cardiac inflammatory conditions (myocarditis, pericarditis)

Outcomes

Primary Outcomes

Change of Anaerobic threshold of 1.5ml/min/kg or more

Time Frame: 6 weeks

Secondary Outcomes

  • Operative outcome(6-10 weeks)

Study Sites (1)

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