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

This study has been completed.
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
First received: January 30, 2009
Last updated: February 15, 2016
Last verified: February 2016
This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.

Condition Intervention
Colorectal Cancer
Other: Cardiopulmonary exercise testing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing

Resource links provided by NLM:

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change of Anaerobic threshold of 1.5ml/min/kg or more [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative outcome [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test arm
Patients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy.
Other: Cardiopulmonary exercise testing
Cardiopulmonary exercise testing involves cycling on an exercise bicycle whilst oxygen consumption and carbon dioxide generation are measured from expired gases. This is used to calculate patient fitness from their peak oxygen consumption and their anaerobic threshold.

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.

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  • Unstable angina with symptoms within 4 days
  • Dissecting aneurysm of aorta
  • Acute pyrexial illness
  • Thyrotoxicosis
  • Syncopal episodes
  • Lower limb thrombosis (arterial or venous)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00833508

United Kingdom
Imperial NHS Trust, St Mary's Hospital, Praed Street
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Principal Investigator: Christopher Stonell, FRCA MBBCh Imperial NHS Trust at St Mary's Hospital
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00833508     History of Changes
Other Study ID Numbers: 08/H0712/117 
Study First Received: January 30, 2009
Last Updated: February 15, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Exercise capacity
Colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on May 26, 2016