NCT02950324

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Royal Surrey County Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-11-01
• Completion: 2022-11-01
• First posted: 2016-11-01
• Last updated: 2016-11-01

Locations

1 site across 1 country: United Kingdom