Exercise Training in Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01325909
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : April 7, 2014
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
Michelle Mossa, Aintree University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Behavioral: Exercise programme Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
Study Start Date : March 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exercise Behavioral: Exercise programme
No Intervention: No Exercise

Primary Outcome Measures :
  1. Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. [ Time Frame: 3 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01325909

United Kingdom
Aintree University Hospitals
Liverpool, United Kingdom, L9 7AL
Sponsors and Collaborators
Michelle Mossa
University Hospital Southampton NHS Foundation Trust
Principal Investigator: Malcolm A West, MD MRCS Aintree University Hospitals NHS Foundation Trust, Liverpool, UK

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michelle Mossa, Research and Development Director, Aintree University Hospitals NHS Foundation Trust Identifier: NCT01325909     History of Changes
Other Study ID Numbers: 11/H1002/12
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases