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

October 27, 2016 updated by: Sophie Allen, Royal Surrey County Hospital NHS Foundation Trust

Does Prehabilitation Improve Performance in Cardiopulmonary Exercise Testing and Reduce Insulin Resistance in Patients Undergoing Neo-adjuvant Treatment and Surgery for Oesophago-gastric Cancer?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital NHS Foundation Trust

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation
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'.
Behavioral: Prehabilitation
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.
Active Comparator: Standard care
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.
Behavioral: Standard care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cardiopulmonary exercise performance
Time Frame: Change in cardiopulmonary exercise performance between week 0 and week 17
Change in cardiopulmonary exercise performance between week 0 and week 17

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in insulin resistance
Time Frame: Change in insulin resistance between week 0 and week 17
Change in insulin resistance between week 0 and week 17
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
Change in quality of life (as assessed by the EORTC QLQ C30 questionnaire) between week 0 and 6 months
Change in grip-strength
Time Frame: Change in grip-strength between 0 weeks and 6 months
Change in grip-strength between 0 weeks and 6 months

Collaborators and Investigators

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

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Sophie Allen, MBBCh, Royal Surrey County Hospital NHS Trust

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

November 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/LO/1702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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