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CompletedNCT00833508Updated Feb 17, 2016

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

An interventional study of Cardiopulmonary exercise testing in Colorectal Cancer, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-02-17.

Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
65 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Colorectal Cancer

Keywords

  • Exercise capacity
  • Chemoradiotherapy
  • Colorectal cancer
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In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 40 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age greater than 65
  • Colorectal cancer requiring preoperative chemoradiotherapy

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Test arm

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

    Other: Cardiopulmonary exercise testing

Interventions

  • OtherCardiopulmonary 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.

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What researchers measure

Primary outcomes

  1. Change of Anaerobic threshold of 1.5ml/min/kg or more

    Time frame: 6 weeks

Secondary outcomes

  1. Operative outcome

    Time frame: 6-10 weeks

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Study locations

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

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. PubMed 8365279 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00833508
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Feb 2, 2009
Start date
Jan 2009
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Feb 17, 2016

Study contacts

Christopher Stonell, FRCA MBBCh
principal investigator · Imperial NHS Trust at St Mary's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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