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

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: NCT01914068
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:

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.


  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:


  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 or disease Intervention/treatment Phase
Rectal Cancer Other: Supervised exercise in hospital Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

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Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    Cardiopulmonary exercise tests will be performed at the time points specified

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Pre NACRT (baseline), Mid NACRT (during treatment week3 to 6 dependent on local policies), week 3,9 of SRETP ]
    Health related quality of life questionnaires will be filled out at each specified time point

  2. Physical activity [ Time Frame: Pre NACRT(baseline), Mid NACRT(during treatment 3 to 6 weeks dependent on local policies), week3, 9 of SRETP ]
    Physical activity monitors, like an armband, will be worn at each specified time point for three days at a time

Other Outcome Measures:
  1. Day 7 post operative morbidity score [ Time Frame: Day 7 post surgery ]
    This will be measured on day 7 post surgery with POMS (post operative morbidity score)

  2. TNM Staging [ Time Frame: Pre NACRT (baseline), week 9 of SRETP and week 14 pre-surgery ]
    MRI scans will be performed at each time point specified to investigate cancer downstaging

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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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): NCT01914068

United Kingdom
Southampton, United Kingdom, SO166YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Principal Investigator: Sandy Jack, MSc, PhD University Hospital Southampton NHS Foundation Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital Southampton NHS Foundation Trust Identifier: NCT01914068     History of Changes
Other Study ID Numbers: PB-PG-0711-25093
PB-PG-0711-25093 ( Other Grant/Funding Number: PB-PG-0711-25093 )
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016

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

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