Exercise Training in Colorectal Cancer Patients

Study Overview
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Brief Summary
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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: Is exercise intervention feasible and tolerable in this cohort of patients? Can fitness be improved using a structured, responsive exercise training programme (SRETP)? Can SRETP improve quality of life? Can SRETP improve physical activity? Can SRETP improve surgical outcome? 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.

Official Title
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Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?

Conditions
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Rectal Cancer

Intervention / Treatment
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* Behavioral: Exercise programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br> | Behavioral: Exercise programme<br> <br> |
| No Intervention: No Exercise<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |