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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Cardiopulmonary exercise testing

• Registration Number: NCT00833508
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test arm	Cardiopulmonary exercise testing	Patients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
Change of Anaerobic threshold of 1.5ml/min/kg or more	6 weeks

Secondary Outcome Measures

Name	Time	Method
Operative outcome	6-10 weeks

Trial Locations

Locations (1)

Imperial NHS Trust, St Mary's Hospital, Praed Street; 🇬🇧 London, United Kingdom