Exercise Prior to Oesophagectomy

Not Applicable

• Conditions: Oesophageal Adenocarcinoma; Postoperative Complications (Cardiopulmonary)
• Interventions: Behavioral: Pre-operative Exercise Programme (my-PEP); Behavioral: Home Exercise Programme (HEP)

• Registration Number: NCT02962219
• Lead Sponsor: University of East Anglia

Brief Summary

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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-28
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-08
• Last Update Submitted: 2016-11-08
• Study First Posted: 2016-11-11
• Last Update Posted: 2016-11-11
• Primary Completion: 2017-09
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pre-operative Exercise Programme (my-PEP)	A pre-operative personalised exercise programme (my-PEP).
Control	Home Exercise Programme (HEP)	Standard care

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of East Anglia; 🇬🇧 Norwich, Norfolk, United Kingdom