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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00833508
First received: January 30, 2009
Last updated: October 7, 2009
Last verified: March 2009
History of Changes
  Purpose

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: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 40
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)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833508

Contacts
Contact: Christopher Stonell, FRCA MBBCh 02078866666 ext 6360 christopher.stonell@imperial.nhs.uk
Contact: David James, MRCS MBBS 02078866666 ext 6840 d.james@imperial.ac.uk

Locations
United Kingdom
Imperial NHS Trust, St Mary's Hospital, Praed Street Recruiting
London, United Kingdom, W2 1NY
Contact: Christopher Stonell         christopher.stonell@imperial.nhs.uk    
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)            
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Christopher Stonell, FRCA MBBCh Imperial NHS Trust at St Mary's Hospital
  More Information

Additional Information:
Consensus Protocol for Pre-operative CPX testing for York, Torbay and UCLH  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr Christopher Stonell, Imperial NHS Trust
ClinicalTrials.gov Identifier: NCT00833508     History of Changes
Other Study ID Numbers: 08/H0712/117
Study First Received: January 30, 2009
Last Updated: October 7, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Exercise capacity
Chemoradiotherapy
Colorectal cancer

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

ClinicalTrials.gov processed this record on May 19, 2013