The Effects of a 9 Week Exercise Programme on Fitness and Quality of Life in Rectal Cancer Patients After Chemoradiotherapy and Before Surgery (SRETP)

This study is currently recruiting participants.
Verified August 2013 by University Hospital Southampton NHS Foundation Trust.
Sponsor:
Collaborator:
AintreeNHSTrust
Information provided by (Responsible Party):
Sandy Jack, University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT01914068
First received: June 7, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

Patients' ability to tolerate surgery is associated with physical fitness: less fit patients have an increased rate of death and serious complications following major surgery. Combined chemotherapy and radiotherapy (x-rays) prior to rectal cancer surgery is known as neo-adjuvant chemoradiotherapy (NACRT) and is associated with improved cancer removal but adversely affects physical fitness. In Liverpool, the investigators have pre-pilot data showing that NACRT reduces objectively measured physical fitness (measured by cardiopulmonary exercise testing) in patients having surgery. This pre-pilot study investigated the effects of a 6-week structured responsive endurance training programme (SRETP) after NACRT and before cancer surgery. This programme has improved both their fitness and their health related quality of life(HRQL). Now, the investigators are undertaking a randomised controlled trial to compare changes in patient's physical fitness in response to SRETP with a group of patients who will be given exercise advice. The SRETP group will exercise 3 times a week for 9 weeks. The investigators will make objective measurements of physical fitness in both groups. The investigators will monitor patient's perceptions of the training programme, HRQL, daily activity (using an accelerometer), and outcomes after surgery. The investigators believe that, patients in the exercise group will improve their physical fitness prior to surgery, change behaviour towards exercise, improve activity and HRQL following NACRT. These results will contribute to the design of a large, multi-centre trial to determine whether a SRETP increases physical fitness with a reduction in adverse outcome following surgery. The investigators will conduct an adequately powered randomized controlled trial (RCT) comparing a SRETP with 'exercise advice' in 46 rectal cancer patients. Specifically, we will test the following hypotheses and outcomes: PRIMARY HYPOTHESIS A 9-week, structured responsive endurance training programme (SRETP) compared with a control group (no training) will result in a clinically significant difference in physical fitness (2.0ml/kg/min VO2 at LT) post-NACRT prior to surgery.

SECONDARY OUTCOMES

  1. A 9-week SRETP compared with a control group (no training) will result in a clinically significant difference in physical fitness (2.0ml/kg/min VO2Peak) in patients who have had NACRT prior to surgery.
  2. SRETP following NACRT and prior to cancer surgery will provide psychological health benefits and improve patient's HRQL (assessed by semi-structured interviews and questionnaires -EORTC QLQ-30 and EQ-5D). This will provide vital exploratory information that will inform a future application to deliver a larger appropriately powered RCT exploring the hypothesis that patients with greater pre-operative fitness will encounter lower postoperative morbidity and mortality. Specifically, these exploratory outcomes are:

EXPLORATORY OUTCOMES

  1. To investigate whether SRETP following NACRT and prior to surgery is associated with a change in overall physical activity (assessed by the number of steps while active using an accelerometer).
  2. To investigate whether there is a change in the day 7 surgical morbidity (using the Post-Operative Morbidity Survey) and mortality.
  3. The effect of SRETP on cancer downstaging post-NACRT (Tumour, Node and Metastasis Staging-TNM staging).

Condition Intervention
Rectal Cancer
Other: Supervised exercise in hospital

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: A Pilot Study to Investigate Improvements in Physical Fitness and Quality of Life Resulting From a 9 Week Structured Responsive Endurance Training Programme (SRETP) Following Neoadjuvant Chemoradiotherapy Prior to Elective Rectal Cancer Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • Change in physical fitness measured by CPET (ml/kg/min) [ Time Frame: Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP ] [ Designated as safety issue: No ]
    Cardiopulmonary exercise tests will be performed at the time points specified


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Pre NACRT (baseline), Mid NACRT (during treatment week3 to 6 dependent on local policies), week 3,9 of SRETP ] [ Designated as safety issue: No ]
    Health related quality of life questionnaires will be filled out at each specified time point

  • Physical activity [ Time Frame: Pre NACRT(baseline), Mid NACRT(during treatment 3 to 6 weeks dependent on local policies), week3, 9 of SRETP ] [ Designated as safety issue: No ]
    Physical activity monitors, like an armband, will be worn at each specified time point for three days at a time


Other Outcome Measures:
  • Day 7 post operative morbidity score [ Time Frame: Day 7 post surgery ] [ Designated as safety issue: No ]
    This will be measured on day 7 post surgery with POMS (post operative morbidity score)

  • TNM Staging [ Time Frame: Pre NACRT (baseline), week 9 of SRETP and week 14 pre-surgery ] [ Designated as safety issue: No ]
    MRI scans will be performed at each time point specified to investigate cancer downstaging


Estimated Enrollment: 46
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No in hospital exercise training and no exercise advice.
Active Comparator: Exercise Intervention
In hospital exercise training
Other: Supervised exercise in hospital

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients listed to undergo elective rectal cancer resection and long course neoadjuvant chemoradiotherapy in the two NHS teaching hospitals (Aintree University Hospital NHS Foundation Trust and Southampton University Hospital NHS Foundation Trust)

Exclusion Criteria:

  • Unable to consent.
  • Under 18 years of age.
  • Unable to perform exercise.
  • Any contraindications on the American Thoracic Surgery CPET safety guidelines.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914068

Contacts
Contact: Lisa Loughney, BSc, MSc ll2y12@soton.ac.uk
Contact: Lisa Loughney Lisa.Loughney@uhs.nhs.uk

Locations
United Kingdom
SouthamptonNHSTrust Recruiting
Southampton, United Kingdom, SO166YD
Contact: Lisa Loughney, BSc, MSc       Lisa.Loughney@uhs.nhs.uk   
Principal Investigator: Sandy Dr Jack, MSc, PhD         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
AintreeNHSTrust
Investigators
Principal Investigator: Sandy Jack, MSc, PhD University Hospital Southampton NHS Foundation Trust.
  More Information

No publications provided

Responsible Party: Sandy Jack, Consultant Clinician Scientist, University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier: NCT01914068     History of Changes
Other Study ID Numbers: PB-PG-0711-25093, PB-PG-0711-25093
Study First Received: June 7, 2013
Last Updated: August 27, 2013
Health Authority: United Kingdom: Research Ethics Committee Centre

Keywords provided by University Hospital Southampton NHS Foundation Trust.:
Neoadjuvant chemoradiotherapy (NACRT)
Rectal cancer
Physical fitness
Exercise programme
Surgery
Stage III/IV
Locally advanced operable
patients

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

ClinicalTrials.gov processed this record on April 17, 2014