Trial Information
Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Change of Anaerobic threshold of 1.5ml/min/kg or more
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Christopher Stonell, FRCA MBBCh
Investigator Role:
Principal Investigator
Investigator Affiliation:
Imperial NHS Trust at St Mary's Hospital
Authority:
United Kingdom: Research Ethics Committee
Study ID:
08/H0712/117
NCT ID:
NCT00833508
Start Date:
January 2009
Completion Date:
October 2011
Related Keywords:
- Colorectal Cancer
- Exercise capacity
- Chemoradiotherapy
- Colorectal cancer
- Colorectal Neoplasms