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Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment (Pre-EMPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626610
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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
Oesophageal Adenocarcinoma Chemotherapy Effect Surgery Behavioral: Exercise prehabilitation during chemotherapy before surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Cardiopulmonary fitness [ Time Frame: Baseline to 5 months ]
    Cardiopulmonary exercise test on bicycle ergometer


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Lean body mass [ Time Frame: Baseline to 5 months ]
    Computerised tomography assessment of lean body mass

  4. Daily activity levels [ Time Frame: Baseline to 5 months ]
    Steps per day measured by Fitbit

  5. Sleep quality assessment [ Time Frame: Baseline to 5 months ]
    Sleep data from Fitbit

  6. Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire [ Time Frame: Baseline to 12 months post-surgery ]
    EORTC QLQ-OES18

  7. Change in Health-related Quality of Life: Cancer questionniare [ Time Frame: Baseline to 12 months post-surgery ]
    EORTC QLQ-C30

  8. Change in Well-being [ Time Frame: Baseline to 12 months post-surgery ]
    SWEMWEBS questionnaire

  9. Disease recurrence [ Time Frame: Date of surgery to date of recurrence, up to 12 months post-surgery ]
    Pathological or radiological confirmation of recurrent disease

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 18+
  3. </=79 (patients above this age may be included in studies after the feasibility study has been completed)
  4. Participants must be able to understand and independently consent to participation in the study.
  5. Participants must be able to understand and complete the questionnaires.
  6. 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.
  7. Participants must be willing to wear the Fibit monitoring device and agree with its use
  8. Participants must be ASA 1-3 and fit for surgical resection
  9. 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:

  1. Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team
  2. Will undergo primary or palliative chemotherapy
  3. Are recommended to have chemoradiotherapy
  4. Are under 18 years old
  5. Are over 79 years old
  6. Are unable to undergo CPEX testing
  7. Do not wish to take part in selected aspects of the study
  8. Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise
  9. Cannot understand and give informed consent to the study
  10. Cannot understand and complete the questionnaires
  11. Do not wish to wear a Fitbit monitoring device
  12. ASA 4+
  13. Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.

Information from the National Library of Medicine

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


Contacts
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Contact: Janine Zylstra +44 (0) 20 7188 7188 ext 52786 janine.zylstra@gstt.nhs.uk
Contact: Andrew Davies, MBChBMDFRCS

Locations
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United Kingdom
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Janine Zylstra       janine.zylstra@gstt.nhs.uk   
Contact: Andrew Davies, MBChBMDFRCS         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Andrew Davies, MBChBMDFRCS Consultant Surgeon
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03626610    
Other Study ID Numbers: IRAS 204711 Pre-EMPT PROTOCOL
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Prehabilitation
Exercise
Cancer
Neo-adjuvant chemotherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms