Cancer Clinical Trial
Official title:
Does Prehabilitation Improve Performance in Cardiopulmonary Exercise Testing and Reduce Insulin Resistance in Patients Undergoing Neo-adjuvant Treatment and Surgery for Oesophago-gastric Cancer?
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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