Exercise Training in Colorectal Cancer Patients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?|
- Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Other measures of physical fitness measured in CPET or the VO2 kinetics test [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Adherence to a 6 week interval exercise intervention. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Optimal time for surgery indicating optimal oncological and physiological fitness [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Health related quality of life improvement as measured by SF36, EORCT c30 v3 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Outcome from major surgery measured by 5 day POMS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Activity levels before during and after neoadjuvant chemoradiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Exercise||Behavioral: Exercise programme|
|No Intervention: No Exercise|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325909
|Aintree University Hospitals|
|Liverpool, United Kingdom, L9 7AL|
|Principal Investigator:||Malcolm A West, MD MRCS||Aintree University Hospitals NHS Foundation Trust, Liverpool, UK|