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Clinical Trials/NCT02962219
NCT02962219UnknownNot Applicable

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

University of East Anglia2 sites in 1 country32 target enrollmentStarted: September 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
32
Locations
2
Primary Endpoint
Recruitment rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: 0 months

The number of participants recruited from all eligible patients

Trial Adherence

Time Frame: 12 months

Physical activity diary used to assess adherence

Change in physical activity levels

Time Frame: 0 and 4 months

Measured with International Physical Activity Questionnaire (IPAQ)

Change in attitudes to exercise

Time Frame: 0 and 4 months

Measured with Determinates of Physical Activity Questionnaire (DPAQ)

Decline rate

Time Frame: 0 months

Number of patients that decline to participate in the trial

Post-operative cardiopulmonary complications

Time Frame: 90-days post surgery

Cardiopulmonary complication rates as per ECCG definition.

Post-operative length of stay

Time Frame: 90-days post surgery

Duration of post-operative stay in days

Drop-out rate

Time Frame: 12 months

Number of patients that drop-out from trial

Change in physiological fitness

Time Frame: 0 and 4 months

Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer

Change in respiratory muscle strength

Time Frame: 0 and 4 months

Assessed with mean inspiratory pressure testing in cmH20

Post-operative mortality

Time Frame: 90-days post surgery

Number of post-operative deaths

Adverse Events

Time Frame: 12 months

The number of adverse events during the trial assessed using CTCAE

Change in Quality of Life

Time Frame: 0, 4, 7 months

Assessed using QLQ C30 and OG25

Post-operative non-cardiopulmonary complications

Time Frame: 90-days post surgery

Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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