Assessment of Fitness After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

NCT01334593 | Completed

• 1 other identifier: 11/H1002/12b
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Rectal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorectal cancer is the third commonest cause of cancer related death (after breast and lung cancer) in the United Kingdom and the second commonest in non smokers. Around 100 new cases of colorectal cancer are diagnosed each day in the UK. In 2002 there were 34,889 new cases of colorectal cancer diagnosed in the United Kingdom, and approximately 17,000 deaths (CRUK 2006). Almost three quarters of bowel cancer cases occur in people aged 65 and over. Within England, mortality rates are generally higher in the north of the country.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michelle Mossa: lead

Study Sites (1)

Aintree University Hospitals

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Related Publications (1)

• West MA, Loughney L, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy on physical fitness and morbidity in rectal cancer surgery patients. Eur J Surg Oncol. 2014 Nov;40(11):1421-8. doi: 10.1016/j.ejso.2014.03.021. Epub 2014 Apr 12.

  PMID: 24784775 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Malcolm A West

  Aintree University Hospitals NHS Foundation Trust, Liverpool, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Research and Development Director

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

GB (1)