Exercise Training in Colorectal Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
University Hospital Southampton NHS Foundation Trust.
Information provided by (Responsible Party):
Michelle Mossa, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01325909
First received: March 29, 2011
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention
Rectal Cancer
Behavioral: Exercise programme

Study Type: Interventional
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?

Resource links provided by NLM:


Further study details as provided by Aintree University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 35
Study Start Date: March 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Behavioral: Exercise programme
No Intervention: No Exercise

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325909

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

No publications provided

Responsible Party: Michelle Mossa, Research and Development Director, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01325909     History of Changes
Other Study ID Numbers: 11/H1002/12
Study First Received: March 29, 2011
Last Updated: April 4, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014