'Pre-EMPT' - A cohort-controlled, interventional study to assess the effects of a pre-emptive exercise programme, or 'prehabilitation', in patients undergoing peri-operative chemotherapy for adenocarcinoma of the lower oesophagus and gastro-oesophageal junction.
Oesophageal cancer has the fastest rising incidence of any solid tumour in the western world with the UK, and London, having particularly high rates of the disease. Those patients being considered for "cure" will benefit from pre-operative/neo-adjuvant chemotherapy (NAC), which is known to have a deleterious effect on fitness and is associated with increased post-operative morbidity. Post-operative morbidity is also associated with reduced survival. Reduction in fitness is compounded by major surgery and significantly reduces the numbers of patients who commence or complete the standard treatment of post-operative chemotherapy to around 40%. Chemotherapy and surgery for oesophageal cancer both represent significant physiological insults that may have detrimental effects on physical activity and outcomes after surgery. Cardiopulmonary exercise (CPEX) testing has been effectively used in numerous tumour groups to predict outcome after surgery, although its role in oesophageal cancer patients remains uncertain owing to conflicting data from institutional series. Advanced exercise programmes, sometimes termed 'prehabilitation', directed by experienced multidisciplinary teams are increasingly being used to mitigate the secondary effects of cancer treatment. 'Prehabilitation' has been shown to reduce postoperative morbidity and mortality in thoracic patients undergoing elective high-risk surgery. In addition, results of studies examining physical exercise and cancer recurrence/survival which effect immune system function in cancer survivors suggest that physical exercise training may improve a number of immune system parameters that may be important in cancer defence. The investigators believe that optimising patient fitness through a structured and expert-devised exercise programme of 'prehabilitation' during neo-adjuvant chemotherapy and prior to surgery will mitigate the effects of chemotherapy and improve patient outcomes after surgery. The investigators intend to assess the feasibility of a 'prehabilitation' programme and quantify the resultant effects primarily using CPEX testing. In addition, changes in hospital 'length of stay' will be documented with a number of additional parameters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
66
Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma
St Thomas' Hospital
London, United Kingdom
RECRUITINGCardiopulmonary fitness
Cardiopulmonary exercise test on bicycle ergometer
Time frame: Baseline to 5 months
Post-operative complications
Clavien-Dindo; ECCG- Esophageal Complications Consensus Group
Time frame: Date of surgery to date of discharge, up to 45 days post-surgery
Post-operative length of hospital stay
Number of in-hospital days from date of surgery
Time frame: Date of surgery to date of discharge, up to 45 days post-surgery
Lean body mass
Computerised tomography assessment of lean body mass
Time frame: Baseline to 5 months
Daily activity levels
Steps per day measured by Fitbit
Time frame: Baseline to 5 months
Sleep quality assessment
Sleep data from Fitbit
Time frame: Baseline to 5 months
Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire
EORTC QLQ-OES18
Time frame: Baseline to 12 months post-surgery
Change in Health-related Quality of Life: Cancer questionniare
EORTC QLQ-C30
Time frame: Baseline to 12 months post-surgery
Change in Well-being
Andrew Davies, MBChBMDFRCS
CONTACT
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SWEMWEBS questionnaire
Time frame: Baseline to 12 months post-surgery
Disease recurrence
Pathological or radiological confirmation of recurrent disease
Time frame: Date of surgery to date of recurrence, up to 12 months post-surgery
Post-operative mortality
In-patient, 30-day, 90-day, 1-year
Time frame: Date of surgery to date of death, up to 12 months post-surgery