The Effects of a 9 Week Exercise Programme on Fitness and Quality of Life in Rectal Cancer Patients After Chemoradiotherapy and Before Surgery
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

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.

      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).
    


Intervention name(s): Supervised exercise in hospital
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Neoadjuvant chemoradiotherapy (NACRT); Rectal cancer; Physical fitness; Exercise programme; Surgery; Stage III/IV; Locally advanced operable; patients