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NCT Number: NCT00833508

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

London, W2 1NY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cardiopulmonary exercise testing

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.

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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2009
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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