Does Prehabilitation Improve Performance in Cardiopulmonary Exercise Testing and Reduce Insulin Resistance in Patients Undergoing Neo-adjuvant Treatment and Surgery for Oesophago-gastric Cancer?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in cardiopulmonary exercise performance
- Last Updated
- 9 years ago
Overview
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.
Investigators
Sophie Allen
Research Fellow
Royal Surrey County Hospital NHS Foundation Trust
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
Outcomes
Primary Outcomes
Change in cardiopulmonary exercise performance
Time Frame: Change in cardiopulmonary exercise performance between week 0 and week 17
Secondary Outcomes
- 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 insulin resistance(Change in insulin resistance between week 0 and week 17)
- Change in grip-strength(Change in grip-strength between 0 weeks and 6 months)