Clinical trial NCT01914068: The Effects of a 9 Week Exercise Programme on Fitness and Quality of Life in Rectal Cancer Patients After Chemoradiotherapy and Before Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Neoadjuvant chemoradiotherapy (NACRT)
Rectal cancer
Physical fitness
Exercise programme
Surgery
Stage III/IV
Locally advanced operable
patients
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: AintreeNHSTrust
First posted: 2013-08-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).


Eligibility 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.

Primary outcomes:
measure: Change in physical fitness measured by CPET (ml/kg/min)
timeFrame: Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP
Secondary outcomes:
measure: Quality of life
timeFrame: Pre NACRT (baseline), Mid NACRT (during treatment week3 to 6 dependent on local policies), week 3,9 of SRETP
measure: Physical activity
timeFrame: Pre NACRT(baseline), Mid NACRT(during treatment 3 to 6 weeks dependent on local policies), week3, 9 of SRETP
Other outcomes:
measure: Day 7 post operative morbidity score
timeFrame: Day 7 post surgery
measure: TNM Staging
timeFrame: Pre NACRT (baseline), week 9 of SRETP and week 14 pre-surgery
Locations:
city: Southampton
country: United Kingdom
facility: SouthamptonNHSTrust
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Sandy Jack, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loughney L, West MA, Moyses H, Bates A, Kemp GJ, Hawkins L, Varkonyi-Sepp J, Burke S, Barben CP, Calverley PM, Cox T, Palmer DH, Mythen MG, Grocott MPW, Jack S; Fit4Surgery group. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial). Perioper Med (Lond). 2021 Jun 22;10(1):23. doi: 10.1186/s13741-021-00190-8.
citation: Loughney L, West MA, Kemp GJ, Rossiter HB, Burke SM, Cox T, Barben CP, Mythen MG, Calverley P, Palmer DH, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial. Trials. 2016 Jan 13;17:24. doi: 10.1186/s13063-015-1149-4.