Exercise Training in Colorectal Cancer Patients
Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
1 other identifier
interventional
35
1 country
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 29, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 7, 2014
April 1, 2014
3.1 years
March 29, 2011
April 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.
3 years
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Exercise
ACTIVE COMPARATORNo Exercise
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust
You may not qualify if:
- Unable to consent
- Under 18 years of age
- Unable to perform exercise
- Meet any contraindications on the ATS CPET safety guidelines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aintree University Hospitals
Liverpool, L9 7AL, United Kingdom
Related Publications (4)
Loughney L, West MA, Dimitrov BD, Kemp GJ, Grocott MP, Jack S. Physical activity levels in locally advanced rectal cancer patients following neoadjuvant chemoradiotherapy and an exercise training programme before surgery: a pilot study. Perioper Med (Lond). 2017 Feb 16;6:3. doi: 10.1186/s13741-017-0058-3. eCollection 2017.
PMID: 28228938DERIVEDBrunet J, Burke S, Grocott MP, West MA, Jack S. The effects of exercise on pain, fatigue, insomnia, and health perceptions in patients with operable advanced stage rectal cancer prior to surgery: a pilot trial. BMC Cancer. 2017 Feb 23;17(1):153. doi: 10.1186/s12885-017-3130-y.
PMID: 28228123DERIVEDWest MA, Dimitrov BD, Moyses HE, Kemp GJ, Loughney L, White D, Grocott MP, Jack S, Brown G. Timing of surgery following neoadjuvant chemoradiotherapy in locally advanced rectal cancer - A comparison of magnetic resonance imaging at two time points and histopathological responses. Eur J Surg Oncol. 2016 Sep;42(9):1350-8. doi: 10.1016/j.ejso.2016.04.003. Epub 2016 Apr 26.
PMID: 27160356DERIVEDWest MA, Loughney L, Lythgoe D, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. Effect of prehabilitation on objectively measured physical fitness after neoadjuvant treatment in preoperative rectal cancer patients: a blinded interventional pilot study. Br J Anaesth. 2015 Feb;114(2):244-51. doi: 10.1093/bja/aeu318. Epub 2014 Oct 1.
PMID: 25274049DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malcolm A West, MD MRCS
Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research and Development Director
Study Record Dates
First Submitted
March 29, 2011
First Posted
March 30, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 7, 2014
Record last verified: 2014-04