Exercise Training in Colorectal Cancer Patients

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Behavioral: Exercise programme

• Registration Number: NCT01325909
• Lead Sponsor: Michelle Mossa

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 have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.

The investigators wish to explore various hypotheses:

1. Is exercise intervention feasible and tolerable in this cohort of patients?

2. Can fitness be improved using a structured, responsive exercise training programme (SRETP)?

3. Can SRETP improve quality of life?

4. Can SRETP improve physical activity?

5. Can SRETP improve surgical outcome?

6. Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.

The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust

Exclusion Criteria

• Unable to consent
• Under 18 years of age
• Unable to perform exercise
• Meet any contraindications on the ATS CPET safety guidelines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise programme	-

Primary Outcome Measures

Name	Time	Method
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.	3 years

Secondary Outcome Measures

Name	Time	Method
Other measures of physical fitness measured in CPET or the VO2 kinetics test	3 years
Adherence to a 6 week interval exercise intervention.	3 years
Optimal time for surgery indicating optimal oncological and physiological fitness	3 years
Health related quality of life improvement as measured by SF36, EORCT c30 v3	3 years
Outcome from major surgery measured by 5 day POMS	3 years
Activity levels before during and after neoadjuvant chemoradiotherapy	3 years

Trial Locations

Locations (1)

Aintree University Hospitals; 🇬🇧 Liverpool, United Kingdom