Exercise Prior to Oesophagectomy

Oesophageal Adenocarcinoma Clinical Trial

— ExPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962219
• Other study ID #: 206608
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2016
• Last updated: November 8, 2016
• Start date: September 2016
• Est. completion date: April 2018

Study information

• Verified date: November 2016
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Oesophageal Adenocarcinoma
• Postoperative Complications
• Postoperative Complications (Cardiopulmonary)

Intervention

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) .
• Home Exercise Programme (HEP)
Written advice on exercise at home

Locations

Country	Name	City	State
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The number of participants recruited from all eligible patients	0 months	No
Primary	Drop-out rate	Number of patients that drop-out from trial	12 months	No
Primary	Decline rate	Number of patients that decline to participate in the trial	0 months	No
Primary	Change in physical activity levels	Measured with International Physical Activity Questionnaire (IPAQ)	0 and 4 months	No
Primary	Change in attitudes to exercise	Measured with Determinates of Physical Activity Questionnaire (DPAQ)	0 and 4 months	No
Primary	Trial Adherence	Physical activity diary used to assess adherence	12 months	No
Primary	Adverse Events	The number of adverse events during the trial assessed using CTCAE	12 months	Yes
Primary	Change in physiological fitness	Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer	0 and 4 months	No
Primary	Change in respiratory muscle strength	Assessed with mean inspiratory pressure testing in cmH20	0 and 4 months	No
Primary	Post-operative cardiopulmonary complications	Cardiopulmonary complication rates as per ECCG definition.	90-days post surgery	No
Primary	Post-operative non-cardiopulmonary complications	Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.	90-days post surgery	No
Primary	Post-operative length of stay	Duration of post-operative stay in days	90-days post surgery	No
Primary	Post-operative mortality	Number of post-operative deaths	90-days post surgery	No
Primary	Change in Quality of Life	Assessed using QLQ C30 and OG25	0, 4, 7 months	No