Clinical trial NCT02962219: Exercise Prior to Oesophagectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications (Cardiopulmonary)
Oesophageal Adenocarcinoma
Keywords: oesophagectomy
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 0 months
measure: Drop-out rate
timeFrame: 12 months
measure: Decline rate
timeFrame: 0 months
measure: Change in physical activity levels
timeFrame: 0 and 4 months
measure: Change in attitudes to exercise
timeFrame: 0 and 4 months
measure: Trial Adherence
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
measure: Change in physiological fitness
timeFrame: 0 and 4 months
measure: Change in respiratory muscle strength
timeFrame: 0 and 4 months
measure: Post-operative cardiopulmonary complications
timeFrame: 90-days post surgery
measure: Post-operative non-cardiopulmonary complications
timeFrame: 90-days post surgery
measure: Post-operative length of stay
timeFrame: 90-days post surgery
measure: Post-operative mortality
timeFrame: 90-days post surgery
measure: Change in Quality of Life
timeFrame: 0, 4, 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
state: Norfolk
Study officials:
References: