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Trial record 14 of 80845 for:    measured

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833508
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Cardiopulmonary exercise testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
Study Start Date : January 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change of Anaerobic threshold of 1.5ml/min/kg or more [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Operative outcome [ Time Frame: 6-10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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)

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 identifier (NCT number): NCT00833508

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

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Responsible Party: Imperial College London Identifier: NCT00833508     History of Changes
Other Study ID Numbers: 08/H0712/117
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Imperial College London:
Exercise capacity
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases