Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment (Pre-EMPT)
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|ClinicalTrials.gov Identifier: NCT03626610|
Recruitment Status : Unknown
Verified August 2018 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oesophageal Adenocarcinoma Chemotherapy Effect Surgery||Behavioral: Exercise prehabilitation during chemotherapy before surgery||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cohort-controlled|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Health Services Research|
|Official Title:||'Pre-EMPT' - An Interventional Study to Assess the Effects of Pre-emptive Exercise , or 'Prehabilitation', in Patients Undergoing Peri-operative Treatment for Adenocarcinoma of the Oesophagus and Gastro-oesophageal Junction|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2021|
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.
- Cardiopulmonary fitness [ Time Frame: Baseline to 5 months ]Cardiopulmonary exercise test on bicycle ergometer
- Post-operative complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to 5 months ]Computerised tomography assessment of lean body mass
- Daily activity levels [ Time Frame: Baseline to 5 months ]Steps per day measured by Fitbit
- Sleep quality assessment [ Time Frame: Baseline to 5 months ]Sleep data from Fitbit
- Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire [ Time Frame: Baseline to 12 months post-surgery ]EORTC QLQ-OES18
- Change in Health-related Quality of Life: Cancer questionniare [ Time Frame: Baseline to 12 months post-surgery ]EORTC QLQ-C30
- Change in Well-being [ Time Frame: Baseline to 12 months post-surgery ]SWEMWEBS questionnaire
- Disease recurrence [ Time Frame: Date of surgery to date of recurrence, up to 12 months post-surgery ]Pathological or radiological confirmation of recurrent disease
- Post-operative mortality [ Time Frame: Date of surgery to date of death, up to 12 months post-surgery ]In-patient, 30-day, 90-day, 1-year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626610
|Contact: Janine Zylstra||+44 (0) 20 7188 7188 ext firstname.lastname@example.org|
|Contact: Andrew Davies, MBChBMDFRCS|
|St Thomas' Hospital||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Janine Zylstra email@example.com|
|Contact: Andrew Davies, MBChBMDFRCS|
|Principal Investigator:||Andrew Davies, MBChBMDFRCS||Consultant Surgeon|