Pre-EMPT: Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment
Study Details
Study Description
Brief Summary
'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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interventional Participants will be given a monitored exercise program during their treatment starting before chemotherapy |
Behavioral: Exercise prehabilitation during chemotherapy before surgery
Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma
|
| No Intervention: Non-interventional Patients will have standard care. |
Outcome Measures
Primary Outcome Measures
- Cardiopulmonary fitness [Baseline to 5 months]
Cardiopulmonary exercise test on bicycle ergometer
Secondary Outcome Measures
- Post-operative complications [Date of surgery to date of discharge, up to 45 days post-surgery]
Clavien-Dindo; ECCG- Esophageal Complications Consensus Group
- Post-operative length of hospital stay [Date of surgery to date of discharge, up to 45 days post-surgery]
Number of in-hospital days from date of surgery
- Lean body mass [Baseline to 5 months]
Computerised tomography assessment of lean body mass
- Daily activity levels [Baseline to 5 months]
Steps per day measured by Fitbit
- Sleep quality assessment [Baseline to 5 months]
Sleep data from Fitbit
- Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire [Baseline to 12 months post-surgery]
EORTC QLQ-OES18
- Change in Health-related Quality of Life: Cancer questionniare [Baseline to 12 months post-surgery]
EORTC QLQ-C30
- Change in Well-being [Baseline to 12 months post-surgery]
SWEMWEBS questionnaire
- Disease recurrence [Date of surgery to date of recurrence, up to 12 months post-surgery]
Pathological or radiological confirmation of recurrent disease
- Post-operative mortality [Date of surgery to date of death, up to 12 months post-surgery]
In-patient, 30-day, 90-day, 1-year
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must be diagnosed with operable oesophageal and gastro-oesophageal adenocarcinoma and scheduled to undergo standard neo-adjuvant chemotherapy and oesophago-gastric surgery as recommended by the Multidisciplinary Meeting decision.
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18+
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</=79 (patients above this age may be included in studies after the feasibility study has been completed)
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Participants must be able to understand and independently consent to participation in the study.
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Participants must be able to understand and complete the questionnaires.
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Participants must be willing to undergo all the standard assessments and interventions included in this study - CPEX testing, blood sampling, questionnaires and exercise intervention where appropriate.
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Participants must be willing to wear the Fibit monitoring device and agree with its use
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Participants must be ASA 1-3 and fit for surgical resection
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Patients should have a Body Mass Index (BMI) equal to or above 18.5 with less than 10% self-reported unintentional weight loss at diagnosis.
Exclusion Criteria:
Participants will be excluded if they:
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Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team
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Will undergo primary or palliative chemotherapy
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Are recommended to have chemoradiotherapy
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Are under 18 years old
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Are over 79 years old
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Are unable to undergo CPEX testing
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Do not wish to take part in selected aspects of the study
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Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise
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Cannot understand and give informed consent to the study
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Cannot understand and complete the questionnaires
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Do not wish to wear a Fitbit monitoring device
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ASA 4+
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Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Thomas' Hospital | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
Investigators
- Principal Investigator: Andrew Davies, MBChBMDFRCS, Consultant Surgeon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRAS 204711 Pre-EMPT PROTOCOL