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

Not Applicable

• Conditions: Cancer

• Registration Number: NCT02950324
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-27
• Last Update Submitted: 2016-10-27
• Study Start: 2016-11
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-01
• Primary Completion: 2018-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in cardiopulmonary exercise performance	Change in cardiopulmonary exercise performance between week 0 and week 17

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Surrey County Hospital NHS Foundation Trust; 🇬🇧 Guildford, United Kingdom