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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833508
• Other study ID #: 08/H0712/117
• Status: Completed
• Phase: N/A
• First received: January 30, 2009
• Last updated: February 15, 2016
• Start date: January 2009
• Est. completion date: October 2011

Study information

• Verified date: February 2016
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Imperial NHS Trust, St Mary's Hospital, Praed Street	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Anaerobic threshold of 1.5ml/min/kg or more		6 weeks	No
Secondary	Operative outcome		6-10 weeks	No