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

This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Cardiopulmonary exercise testing

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1NY
    • Imperial NHS Trust, St Mary's Hospital, Praed Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of Anaerobic threshold of 1.5ml/min/kg or more	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative outcome	6-10 weeks

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Christopher Stonell, FRCA MBBCh, Imperial NHS Trust at St Mary's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 2, 2009

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Colorectal cancer; Chemoradiotherapy; Exercise capacity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 08/H0712/117