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

NCT ID: NCT00833508

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Test arm

Patients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy.

Group Type EXPERIMENTAL

Cardiopulmonary exercise testing

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Stonell, FRCA MBBCh

Role: PRINCIPAL_INVESTIGATOR

Imperial NHS Trust at St Mary's Hospital

Locations

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Imperial NHS Trust, St Mary's Hospital, Praed Street

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 8365279 (View on PubMed)

Other Identifiers

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08/H0712/117

Identifier Type: -

Identifier Source: org_study_id

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