Assessment of Fitness After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334593
• Other study ID #: 11/H1002/12b
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: December 29, 2012
• Start date: August 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: Aintree University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators aim to obtain pilot data showing that neoadjuvant chemoradiotherapy (NACRT)reduces objectively measured exercise capacity (fitness).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United Kingdom	Aintree University Hospitals	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Michelle Mossa

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients.	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	2 years	No