Back to resultsEffect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cardiopulmonary exercise testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Exercise capacity, Chemoradiotherapy, Colorectal cancer
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)
- Unstable angina with symptoms within 4 days
- Dissecting aneurysm of aorta
- Acute pyrexial illness
- Thyrotoxicosis
- Syncopal episodes
- Lower limb thrombosis (arterial or venous)
Sites / Locations
- Imperial NHS Trust, St Mary's Hospital, Praed Street
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test arm
Arm Description
Patients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy.
Outcomes
Primary Outcome Measures
Change of Anaerobic threshold of 1.5ml/min/kg or more
Secondary Outcome Measures
Operative outcome
Full Information
NCT ID
NCT00833508
First Posted
January 30, 2009
Last Updated
February 15, 2016
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT00833508
Brief Title
Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
Official Title
Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Exercise capacity, Chemoradiotherapy, Colorectal cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test arm
Arm Type
Experimental
Arm Description
Patients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary exercise testing
Intervention Description
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 Measure Information:
Title
Change of Anaerobic threshold of 1.5ml/min/kg or more
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Operative outcome
Time Frame
6-10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Unstable angina with symptoms within 4 days
Dissecting aneurysm of aorta
Acute pyrexial illness
Thyrotoxicosis
Syncopal episodes
Lower limb thrombosis (arterial or venous)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Stonell, FRCA MBBCh
Organizational Affiliation
Imperial NHS Trust at St Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial NHS Trust, St Mary's Hospital, Praed Street
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
8365279
Citation
Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701.
Results Reference
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Learn more about this trial
Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
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