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'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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Participants will be given a monitored exercise program during their treatment starting before chemotherapy |
|
| Non-interventional | No Intervention | Patients will have standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise prehabilitation during chemotherapy before surgery | Behavioral | Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary fitness | Cardiopulmonary exercise test on bicycle ergometer | Baseline to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative complications | Clavien-Dindo; ECCG- Esophageal Complications Consensus Group | Date of surgery to date of discharge, up to 45 days post-surgery |
| Post-operative length of hospital stay |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janine Zylstra | Contact | +44 (0) 20 7188 7188 | 52786 | janine.zylstra@gstt.nhs.uk |
| Andrew Davies, MBChBMDFRCS | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Davies, MBChBMDFRCS | Consultant Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Thomas' Hospital | Recruiting | London | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35105604 | Derived | Zylstra J, Whyte GP, Beckmann K, Pate J, Santaolalla A, Gervais-Andre L, Russell B, Maisey N, Waters J, Tham G, Lagergren J, Green M, Kelly M, Baker C, Van Hemelrijck M, Goh V, Gossage J, Browning M, Davies A. Exercise prehabilitation during neoadjuvant chemotherapy may enhance tumour regression in oesophageal cancer: results from a prospective non-randomised trial. Br J Sports Med. 2022 Apr;56(7):402-409. doi: 10.1136/bjsports-2021-104243. Epub 2022 Feb 1. |
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| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Cohort-controlled
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Number of in-hospital days from date of surgery
| Date of surgery to date of discharge, up to 45 days post-surgery |
| Lean body mass | Computerised tomography assessment of lean body mass | Baseline to 5 months |
| Daily activity levels | Steps per day measured by Fitbit | Baseline to 5 months |
| Sleep quality assessment | Sleep data from Fitbit | Baseline to 5 months |
| Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire | EORTC QLQ-OES18 | Baseline to 12 months post-surgery |
| Change in Health-related Quality of Life: Cancer questionniare | EORTC QLQ-C30 | Baseline to 12 months post-surgery |
| Change in Well-being | SWEMWEBS questionnaire | Baseline to 12 months post-surgery |
| Disease recurrence | Pathological or radiological confirmation of recurrent disease | Date of surgery to date of recurrence, up to 12 months post-surgery |
| Post-operative mortality | In-patient, 30-day, 90-day, 1-year | Date of surgery to date of death, up to 12 months post-surgery |