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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | 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'. |
|
| Standard care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiopulmonary exercise performance | Change in cardiopulmonary exercise performance between week 0 and week 17 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Allen, MBBCh | Contact | 07733 258752 | sophieallen@doctors.org.uk | |
| Sarah Martin | Contact | sarah.martin33@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Sophie Allen, MBBCh | Royal Surrey County Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey County Hospital NHS Foundation Trust | Guildford | GU2 7XX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34725764 | Derived | 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. | |
| 30580268 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
| Standard care | Behavioral | 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. |
|
| Change in grip-strength | Change in grip-strength between 0 weeks and 6 months |
| Derived |
| 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |