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

August 8, 2018 updated by: Guy's and St Thomas' NHS Foundation Trust

'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

'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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary fitness
Time Frame: Baseline to 5 months
Cardiopulmonary exercise test on bicycle ergometer
Baseline to 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Date of surgery to date of discharge, up to 45 days post-surgery
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
Date of surgery to date of discharge, up to 45 days post-surgery
Lean body mass
Time Frame: Baseline to 5 months
Computerised tomography assessment of lean body mass
Baseline to 5 months
Daily activity levels
Time Frame: Baseline to 5 months
Steps per day measured by Fitbit
Baseline to 5 months
Sleep quality assessment
Time Frame: Baseline to 5 months
Sleep data from Fitbit
Baseline to 5 months
Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire
Time Frame: Baseline to 12 months post-surgery
EORTC QLQ-OES18
Baseline to 12 months post-surgery
Change in Health-related Quality of Life: Cancer questionniare
Time Frame: Baseline to 12 months post-surgery
EORTC QLQ-C30
Baseline to 12 months post-surgery
Change in Well-being
Time Frame: Baseline to 12 months post-surgery
SWEMWEBS questionnaire
Baseline to 12 months post-surgery
Disease recurrence
Time Frame: Date of surgery to date of recurrence, up to 12 months post-surgery
Pathological or radiological confirmation of recurrent disease
Date of surgery to date of recurrence, up to 12 months post-surgery
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
Date of surgery to date of death, up to 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Andrew Davies, MBChBMDFRCS, Consultant Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (ACTUAL)

August 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS 204711 Pre-EMPT PROTOCOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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