Exercise Prior to Oesophagectomy

NCT ID: NCT02962219

Last Updated: 2016-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-04-30

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.

Conditions

Postoperative Complications (Cardiopulmonary); Oesophageal Adenocarcinoma

Keywords

oesophagectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

A pre-operative personalised exercise programme (my-PEP).

Group Type: EXPERIMENTAL

Pre-operative Exercise Programme (my-PEP)

Intervention Type: BEHAVIORAL

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) .

Control

Standard care

Group Type: OTHER

Home Exercise Programme (HEP)

Intervention Type: BEHAVIORAL

Written advice on exercise at home

Interventions

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) .

Intervention Type: BEHAVIORAL

Home Exercise Programme (HEP)

Written advice on exercise at home

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of East Anglia

Norwich, Norfolk, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Professor Andrew Hart

Role: primary

Dr Stephen Lam

Role: backup

Other Identifiers

206608

Identifier Type: -

Identifier Source: org_study_id