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The Effect of Neoadjuvant Chemoradiotherapy on Exercise Capacity in Colrectal Cancer Patients

18 Years
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Trial Information

The Effect of Neoadjuvant Chemoradiotherapy on Exercise Capacity in Colrectal Cancer Patients

Purpose: To evaluate the effects of chemoradiotherapy on pre−operative fitness of patients
prior to major colorectal cancer surgery.

Design: Patients will act as their own case−control.

Patients will be consented at the earliest available opportunity following the decision that
they have surgically treatable disease and they consent to pre−operative NACRT. Consent for
the study will be gained as an outpatient. At "visit 1" patients will undergo CPET, as is
our current standard practice, prior to commencing neoadjuvant chemoradiotherapy. As part of
the assessment, they will have pulmonary function testing (static lung volumes, lung
diffusing capacity). They will then undergo 6 weeks of long course NACRT, as is standard
current practice at our institution. At "visit 2", approximately four to six weeks following
chemoradiotherapy another CPET test will be repeated. This is also current standard practice
at our institution. Data from visit 1 and visit 2 will be compared in a paired manner. A
statistician will be consulted to assess the degree of normality of the data, the
statistical tests to use, and for power calculations. At no point will any treatments be
postponed or changed solely for the purposes of collecting data for the research.

Inclusion Criteria:

- All patients listed to undergo neoadjuvant chemoradiotherapy for downstaging of
colorectal cancer, with a view to undergo elective colorectal surgery at Aintree
University Hospitals.

Exclusion Criteria:

- Unable to consent.

- Under 18 years of age.

- Significant ischaemic changes of >1.5mm symptomatic and > 2mm asymptomatic observed
on routine cardiopulmonary exercise test.

- Any other absolute contraindications to CPET based on the ATS guidelines.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients.

Outcome Description:

Exercise capacity (fitness) before and after NACRT will be assessed using CPET.We have pilot data on an upper gastrointestinal cancer cohort that shows that neoadjuvant chemotherapy alone results in lower levels of fitness (mean fall VO2@LT of 2.19ml/kg/min), which relates to survival before stomach and oesophageal surgery in a group of patients in Liverpool. These data also suggest that the insult of chemotherapy and surgery increases mortality

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Malcolm A West

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aintree University Hospitals NHS Foundation Trust, Liverpool, UK


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

August 2011

Completion Date:

July 2012

Related Keywords:

  • Cancer