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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Prehabilitation
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>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<br>* 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.<br>|
| Active Comparator: Standard care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiopulmonary exercise performance |  | Change in cardiopulmonary exercise performance between week 0 and week 17 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Oesophago-gastric, Cancer, Neo-adjuvant, Exercise, Cardiopulmonary exercise test, Insulin resistance