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Does Prehabilitation Improve Exercise Performance and Insulin Resistance After Surgery for Oesophago-gastric Cancer?

Primary Purpose

Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Prehabilitation
Standard care
Sponsored by
Royal Surrey County Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Prehabilitation, Oesophago-gastric, Cancer, Neo-adjuvant, Exercise, Cardiopulmonary exercise test, Insulin resistance

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients listed for elective oesophagectomy or total gastrectomy for cancer
  • Must have capacity to consent
  • Age 18-99

Exclusion Criteria:

  • Known contraindication for CPX
  • Physically unable to perform CPX test or undertake prehabilitation exercise programme
  • Pregnant patients or those planning to become pregnant
  • Lack of capacity to give informed consent

Sites / Locations

  • Royal Surrey County Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prehabilitation

Standard care

Arm Description

Patients in this (intervention) arm of the study will be enrolled into a multimodal programme that involves 15 weeks of exercise, nutritional support and psychological prehabilitation in the form of 'Medical Coaching'.

Patients in the 'standard care' arm of the study will not receive the study intervention. The patients will continue to be offered the standard dietetic and psychological support as per the enhanced recovery pathway and current standard of care.

Outcomes

Primary Outcome Measures

Change in cardiopulmonary exercise performance

Secondary Outcome Measures

Change in insulin resistance
Change in quality of life
Change in grip-strength

Full Information

First Posted
October 13, 2016
Last Updated
October 27, 2016
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02950324
Brief Title
Does Prehabilitation Improve Exercise Performance and Insulin Resistance After Surgery for Oesophago-gastric Cancer?
Official Title
Does Prehabilitation Improve Performance in Cardiopulmonary Exercise Testing and Reduce Insulin Resistance in Patients Undergoing Neo-adjuvant Treatment and Surgery for Oesophago-gastric Cancer?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Surrey County Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of a multimodal pre-operative prehabilitation programme during neo-adjuvant therapy on cardiopulmonary exercise performance and insulin resistance prior to resection for oesophago-gastric cancer.
Detailed Description
The trial objectives are as follows: Primary: To evaluate the effect of a prehabilitation programme during neo-adjuvant therapy on CPX performance prior to resection for oesophago-gastric cancer. Secondary: To investigate the impact of neo-adjuvant chemotherapy on insulin resistance; to determine whether a prehabilitation exercise programme is feasible during neo-adjuvant chemotherapy; to determine whether rehabilitation has a positive impact on quality of life outcomes; to investigate the impact of prehabilitation on clinical outcomes; to assess the effect of prehabilitation on nutritional status; to determine whether prehabilitation affects the stress response to surgery. This study is a randomised controlled trial where patients will be stratified into 'fit' and 'unfit' groups based upon their anaerobic threshold and then randomised in a 1:1 ratio to receive multimodal prehabilitation or standard care prior to OG cancer surgery, during neo-adjuvant chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Prehabilitation, Oesophago-gastric, Cancer, Neo-adjuvant, Exercise, Cardiopulmonary exercise test, Insulin resistance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
Patients in this (intervention) arm of the study will be enrolled into a multimodal programme that involves 15 weeks of exercise, nutritional support and psychological prehabilitation in the form of 'Medical Coaching'.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Patients in the 'standard care' arm of the study will not receive the study intervention. The patients will continue to be offered the standard dietetic and psychological support as per the enhanced recovery pathway and current standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation
Intervention Description
Patients in the intervention, 'Prehabilitation', arm of the study will be enrolled into a multimodal programme that involves 15 weeks of exercise, nutritional support and psychological prehabilitation in the form of 'Medical Coaching'. This will take place during neo-adjuvant treatment prior to oesophagectomy or gastrectomy for cancer.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Patients in the 'standard care' arm of the study will not receive the study intervention. The patients will continue to be offered theatients in this arm of the study will not receive the study intervention. The patients will continue to be offered the standard dietetic and psychological support as per the enhanced recovery pathway and current standard of care standard dietetic and psychological support as per the enhanced recovery pathway and current standard of care.
Primary Outcome Measure Information:
Title
Change in cardiopulmonary exercise performance
Time Frame
Change in cardiopulmonary exercise performance between week 0 and week 17
Secondary Outcome Measure Information:
Title
Change in insulin resistance
Time Frame
Change in insulin resistance between week 0 and week 17
Title
Change in quality of life
Time Frame
Change in quality of life (as assessed by the EORTC QLQ C30 questionnaire) between week 0 and 6 months
Title
Change in grip-strength
Time Frame
Change in grip-strength between 0 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients listed for elective oesophagectomy or total gastrectomy for cancer Must have capacity to consent Age 18-99 Exclusion Criteria: Known contraindication for CPX Physically unable to perform CPX test or undertake prehabilitation exercise programme Pregnant patients or those planning to become pregnant Lack of capacity to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Allen, MBBCh
Phone
07733 258752
Email
sophieallen@doctors.org.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Martin
Email
sarah.martin33@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Allen, MBBCh
Organizational Affiliation
Royal Surrey County Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Allen, MBBCh
Phone
07733 258752
Email
sophieallen@doctors.org.uk
First Name & Middle Initial & Last Name & Degree
Javed Sultan
Email
jav4144@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34725764
Citation
Allen SK, Brown V, White D, King D, Hunt J, Wainwright J, Emery A, Hodge E, Kehinde A, Prabhu P, Rockall TA, Preston SR, Sultan J. Multimodal Prehabilitation During Neoadjuvant Therapy Prior to Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass and Quality of Life-A Pilot Randomized Clinical Trial. Ann Surg Oncol. 2022 Mar;29(3):1839-1850. doi: 10.1245/s10434-021-11002-0. Epub 2021 Nov 1.
Results Reference
derived
PubMed Identifier
30580268
Citation
Allen S, Brown V, Prabhu P, Scott M, Rockall T, Preston S, Sultan J. A randomised controlled trial to assess whether prehabilitation improves fitness in patients undergoing neoadjuvant treatment prior to oesophagogastric cancer surgery: study protocol. BMJ Open. 2018 Dec 22;8(12):e023190. doi: 10.1136/bmjopen-2018-023190.
Results Reference
derived

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Does Prehabilitation Improve Exercise Performance and Insulin Resistance After Surgery for Oesophago-gastric Cancer?

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