Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
Recruitment status was Recruiting
This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.
|Study Design:||Allocation: Non-Randomized
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|
- Change of Anaerobic threshold of 1.5ml/min/kg or more [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Operative outcome [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833508
|Contact: Christopher Stonell, FRCA MBBCh||02078866666 ext firstname.lastname@example.org|
|Contact: David James, MRCS MBBS||02078866666 ext email@example.com|
|Imperial NHS Trust, St Mary's Hospital, Praed Street||Recruiting|
|London, United Kingdom, W2 1NY|
|Contact: Christopher Stonell firstname.lastname@example.org|
|Sub-Investigator: Paraskevas Paraskeva, FRCS PhD|
|Sub-Investigator: David James, MRCS MBBS|
|Sub-Investigator: Sanjay Purkayastha, MRCS MD|
|Sub-Investigator: Darrel Francis, FRCP|
|Sub-Investigator: Todd Smith, BSc(Hons)|
|Principal Investigator:||Christopher Stonell, FRCA MBBCh||Imperial NHS Trust at St Mary's Hospital|