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Exercise Training in Colorectal Cancer Patients

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise programme
Sponsored by
Michelle Mossa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aintree University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercise

No Exercise

Arm Description

Outcomes

Primary Outcome Measures

Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2011
Last Updated
April 4, 2014
Sponsor
Michelle Mossa
Collaborators
University Hospital Southampton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01325909
Brief Title
Exercise Training in Colorectal Cancer Patients
Official Title
Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle Mossa
Collaborators
University Hospital Southampton NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Active Comparator
Arm Title
No Exercise
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise programme
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Other measures of physical fitness measured in CPET or the VO2 kinetics test
Time Frame
3 years
Title
Adherence to a 6 week interval exercise intervention.
Time Frame
3 years
Title
Optimal time for surgery indicating optimal oncological and physiological fitness
Time Frame
3 years
Title
Health related quality of life improvement as measured by SF36, EORCT c30 v3
Time Frame
3 years
Title
Outcome from major surgery measured by 5 day POMS
Time Frame
3 years
Title
Activity levels before during and after neoadjuvant chemoradiotherapy
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm A West, MD MRCS
Organizational Affiliation
Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aintree University Hospitals
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28228938
Citation
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.
Results Reference
derived
PubMed Identifier
28228123
Citation
Brunet 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.
Results Reference
derived
PubMed Identifier
27160356
Citation
West 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.
Results Reference
derived
PubMed Identifier
25274049
Citation
West 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.
Results Reference
derived

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Exercise Training in Colorectal Cancer Patients

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