Cancer
Conditions
Keywords
Prehabilitation, Oesophago-gastric, Cancer, Neo-adjuvant, Exercise, Cardiopulmonary exercise test, Insulin resistance
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.
Interventions
BEHAVIORALPrehabilitation
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.
BEHAVIORALStandard 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.
Sponsors
Royal Surrey County Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cardiopulmonary exercise performance | Change in cardiopulmonary exercise performance between week 0 and week 17 |
Secondary
| Measure | 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 |
Countries
United Kingdom
Contacts
Primary ContactSophie Allen, MBBCh
Backup ContactSarah Martin
Outcome results
None listed