Exercise Prior to Oesophagectomy (ExPO)

A Pre-operative Personalised Exercise Programme to Improve Physical Fitness and Reduce Post-operative Cardiopulmonary Complications After Oesophagectomy in Patients With Oesophageal Adenocarcinoma: A Feasibility Randomised Controlled Trial

The purpose of this feasibility study is to determine whether a structured exercise programme prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological measures of physical fitness above standard care.

Study Overview

• Status: Unknown
• Conditions: Oesophageal Adenocarcinoma; Postoperative Complications (Cardiopulmonary)
• Intervention / Treatment: Behavioral: Pre-operative Exercise Programme (my-PEP); Behavioral: Home Exercise Programme (HEP)

Detailed Description

The number of patients with oesophageal cancer is rising dramatically in the UK. Curative cancer surgery (oesophagectomy) is offered to around 40% of affected patients. However, oesophagectomy is a major operation with a high risk of complications. Around 1 in 3 patients will suffer such a complication after surgery, mostly due to heart or lung problems. Most complications are not due to the surgery itself, but related to the patient's physical fitness before their operation. Studies in other surgeries, but not oesophagectomy, have shown that complications may be reduced by improving a patient's physical fitness before their operation. The ExPO team has developed a pre-operative Personalised Exercise Programme (my-PEP), specifically for patients undergoing oesophagectomy. my-PEP has 4 main components: three are exercise modalities (aerobic exercise, breathing exercises and muscle strengthening); the fourth is where a participant's potential barriers to exercise are assessed and behavioural change techniques (BCTs) are suggested to improve exercise engagement in the trial. In total, 32 patients who are due to undergo oesophagectomy at the Norfolk and Norwich Hospital will be recruited and then randomly divided into 2 arms of 16 each. One arm will receive my-PEP in the standard 3-4 months prior to surgery, the other will receive standard care advice to exercise at home. The research objectives are to obtain feasibility data on whether my-PEP is acceptable, adhered to and safe, and whether it improves patient fitness above standard care. Follow up will be 90 days after surgery to obtain a preliminary imprecise estimate of whether my-PEP reduces complications. If the ExPO trial shows promise in these areas, this will inform and justify a future large multi-centre trial to definitively answer whether my-PEP can reduce complications after oesophagectomy. If so, my-PEP could potentially change and improve the pre-operative management of oesophageal cancer patients across the NHS.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7TJ
      • Recruiting
      • University of East Anglia
      • Contact: Professor Andrew Hart; Phone Number: 01603 593611; Email: a.hart@uea.ac.uk
      • Contact: Dr Stephen Lam; Phone Number: 01603 286286; Email: stephen.lam@uea.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with oesophageal adenocarcinoma (OAC) who are scheduled for neoadjuvant chemotherapy and subsequent oesophagectomy.
• Must have histological evidence of OAC
• Must be capable of giving informed consent and complying with trial procedures.

Exclusion Criteria:

• Patients with oesophageal squamous cell carcinoma.
• Patients with concomitant illness or disability that makes them unsuitable for an exercise programme, as determined by a clinician (e.g. severe musculoskeletal or neurological disease, unstable angina, severe aortic stenosis, uncontrolled dysrhythmias and uncompensated heart failure).
• WHO performance status 3 (capable of only limited self-care, confined to a bed or chair more that 50% of waking hours) or greater.
• Grade 5 (too breathless to leave the house, or breathless when undressing) on MRC dyspnoea scale.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Standard care	Behavioral: Home Exercise Programme (HEP); Written advice on exercise at home
Experimental: Intervention; A pre-operative personalised exercise programme (my-PEP).	Behavioral: Pre-operative Exercise Programme (my-PEP); A pre-operative personalised exercise programme (my-PEP) consisting of: 1) actions to promote exercise, using behavioural change techniques (BCTs), 2) home inspiratory muscle training (IMT), 3) a home exercise programme (HEP) - which is also current standard care, 4) a 4 week hospital-supervised aerobic and muscle strengthening programme (Hos-PEP) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	The number of participants recruited from all eligible patients	0 months
Drop-out rate	Number of patients that drop-out from trial	12 months
Decline rate	Number of patients that decline to participate in the trial	0 months
Change in physical activity levels	Measured with International Physical Activity Questionnaire (IPAQ)	0 and 4 months
Change in attitudes to exercise	Measured with Determinates of Physical Activity Questionnaire (DPAQ)	0 and 4 months
Trial Adherence	Physical activity diary used to assess adherence	12 months
Adverse Events	The number of adverse events during the trial assessed using CTCAE	12 months
Change in physiological fitness	Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer	0 and 4 months
Change in respiratory muscle strength	Assessed with mean inspiratory pressure testing in cmH20	0 and 4 months
Post-operative cardiopulmonary complications	Cardiopulmonary complication rates as per ECCG definition.	90-days post surgery
Post-operative non-cardiopulmonary complications	Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.	90-days post surgery
Post-operative length of stay	Duration of post-operative stay in days	90-days post surgery
Post-operative mortality	Number of post-operative deaths	90-days post surgery
Change in Quality of Life	Assessed using QLQ C30 and OG25	0, 4, 7 months

Collaborators and Investigators

• Sponsor: University of East Anglia

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 8, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: oesophagectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Postoperative Complications; Esophageal Neoplasms
• Other Study ID Numbers: 206608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO