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


N/A
65 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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.


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‚ąímorbidity 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Christopher Stonell, FRCA MBBCh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Imperial NHS Trust at St Mary's Hospital

Authority:

United Kingdom: Research Ethics Committee

Study ID:

08/H0712/117

NCT ID:

NCT00833508

Start Date:

January 2009

Completion Date:

October 2011

Related Keywords:

  • Colorectal Cancer
  • Exercise capacity
  • Chemoradiotherapy
  • Colorectal cancer
  • Colorectal Neoplasms

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