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

NCT01914068 | Completed DMC

• 1 other identifier: PB-PG-0711-25093
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 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. 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:
3. 3.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).
4. 4.To investigate whether there is a change in the day 7 surgical morbidity (using the Post-Operative Morbidity Survey) and mortality.
5. 5.The effect of SRETP on cancer downstaging post-NACRT (Tumour, Node and Metastasis Staging-TNM staging).

Conditions

Rectal Cancer

Keywords

Neoadjuvant chemoradiotherapy (NACRT); Rectal cancer; Physical fitness; Exercise programme; Surgery; Stage III/IV; Locally advanced operable; patients

Outcome Measures

Primary Outcomes (1)

• Change in physical fitness measured by CPET (ml/kg/min)

  Cardiopulmonary exercise tests will be performed at the time points specified

  Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP

Secondary Outcomes (2)

• Quality of life

  Pre NACRT (baseline), Mid NACRT (during treatment week3 to 6 dependent on local policies), week 3,9 of SRETP

• Physical activity

  Pre NACRT(baseline), Mid NACRT(during treatment 3 to 6 weeks dependent on local policies), week3, 9 of SRETP

Other Outcomes (2)

• Day 7 post operative morbidity score

  Day 7 post surgery

• TNM Staging

  Pre NACRT (baseline), week 9 of SRETP and week 14 pre-surgery

Study Arms (2)

Control

NO INTERVENTION

No in hospital exercise training and no exercise advice.

Exercise Intervention

ACTIVE COMPARATOR

In hospital exercise training

Other: Supervised exercise in hospital

Interventions

Supervised exercise in hospital OTHER

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unable to consent.
• Under 18 years of age.
• Unable to perform exercise.
• Any contraindications on the American Thoracic Surgery CPET safety guidelines.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• AintreeNHSTrust: collaborator

Study Sites (1)

SouthamptonNHSTrust

Southampton, SO166YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34154675 DERIVED

• 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.

  PMID: 26762365 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Hospitals

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Sandy Jack, MSc, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: August 1, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

GB (1)