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

Primary Purpose

Oesophageal Adenocarcinoma, Chemotherapy Effect, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise prehabilitation during chemotherapy before surgery
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Oesophageal Adenocarcinoma focused on measuring Prehabilitation, Exercise, Cancer, Neo-adjuvant chemotherapy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Thomas' HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional

Non-interventional

Arm Description

Participants will be given a monitored exercise program during their treatment starting before chemotherapy

Patients will have standard care.

Outcomes

Primary Outcome Measures

Cardiopulmonary fitness
Cardiopulmonary exercise test on bicycle ergometer

Secondary Outcome Measures

Post-operative complications
Clavien-Dindo; ECCG- Esophageal Complications Consensus Group
Post-operative length of hospital stay
Number of in-hospital days from date of surgery
Lean body mass
Computerised tomography assessment of lean body mass
Daily activity levels
Steps per day measured by Fitbit
Sleep quality assessment
Sleep data from Fitbit
Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire
EORTC QLQ-OES18
Change in Health-related Quality of Life: Cancer questionniare
EORTC QLQ-C30
Change in Well-being
SWEMWEBS questionnaire
Disease recurrence
Pathological or radiological confirmation of recurrent disease
Post-operative mortality
In-patient, 30-day, 90-day, 1-year

Full Information

First Posted
July 24, 2018
Last Updated
August 8, 2018
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03626610
Brief Title
Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment
Acronym
Pre-EMPT
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Adenocarcinoma, Chemotherapy Effect, Surgery
Keywords
Prehabilitation, Exercise, Cancer, Neo-adjuvant chemotherapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cohort-controlled
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Participants will be given a monitored exercise program during their treatment starting before chemotherapy
Arm Title
Non-interventional
Arm Type
No Intervention
Arm Description
Patients will have standard care.
Intervention Type
Behavioral
Intervention Name(s)
Exercise prehabilitation during chemotherapy before surgery
Intervention Description
Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma
Primary Outcome Measure Information:
Title
Cardiopulmonary fitness
Description
Cardiopulmonary exercise test on bicycle ergometer
Time Frame
Baseline to 5 months
Secondary Outcome Measure Information:
Title
Post-operative complications
Description
Clavien-Dindo; ECCG- Esophageal Complications Consensus Group
Time Frame
Date of surgery to date of discharge, up to 45 days post-surgery
Title
Post-operative length of hospital stay
Description
Number of in-hospital days from date of surgery
Time Frame
Date of surgery to date of discharge, up to 45 days post-surgery
Title
Lean body mass
Description
Computerised tomography assessment of lean body mass
Time Frame
Baseline to 5 months
Title
Daily activity levels
Description
Steps per day measured by Fitbit
Time Frame
Baseline to 5 months
Title
Sleep quality assessment
Description
Sleep data from Fitbit
Time Frame
Baseline to 5 months
Title
Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire
Description
EORTC QLQ-OES18
Time Frame
Baseline to 12 months post-surgery
Title
Change in Health-related Quality of Life: Cancer questionniare
Description
EORTC QLQ-C30
Time Frame
Baseline to 12 months post-surgery
Title
Change in Well-being
Description
SWEMWEBS questionnaire
Time Frame
Baseline to 12 months post-surgery
Title
Disease recurrence
Description
Pathological or radiological confirmation of recurrent disease
Time Frame
Date of surgery to date of recurrence, up to 12 months post-surgery
Title
Post-operative mortality
Description
In-patient, 30-day, 90-day, 1-year
Time Frame
Date of surgery to date of death, up to 12 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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. 18+ </=79 (patients above this age may be included in studies after the feasibility study has been completed) Participants must be able to understand and independently consent to participation in the study. Participants must be able to understand and complete the questionnaires. 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. Participants must be willing to wear the Fibit monitoring device and agree with its use Participants must be ASA 1-3 and fit for surgical resection 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: Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team Will undergo primary or palliative chemotherapy Are recommended to have chemoradiotherapy Are under 18 years old Are over 79 years old Are unable to undergo CPEX testing Do not wish to take part in selected aspects of the study Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise Cannot understand and give informed consent to the study Cannot understand and complete the questionnaires Do not wish to wear a Fitbit monitoring device ASA 4+ Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janine Zylstra
Phone
+44 (0) 20 7188 7188
Ext
52786
Email
janine.zylstra@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Davies, MBChBMDFRCS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Davies, MBChBMDFRCS
Organizational Affiliation
Consultant Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Zylstra
Email
janine.zylstra@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Andrew Davies, MBChBMDFRCS

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35105604
Citation
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.
Results Reference
derived

Learn more about this trial

Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment

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