Clinical trial NCT02950324: Does Prehabilitation Improve Exercise Performance and Insulin Resistance After Surgery for Oesophago-gastric Cancer?
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Prehabilitation
Oesophago-gastric
Cancer
Neo-adjuvant
Exercise
Cardiopulmonary exercise test
Insulin resistance
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in cardiopulmonary exercise performance
timeFrame: Change in cardiopulmonary exercise performance between week 0 and week 17
Secondary outcomes:
measure: Change in insulin resistance
timeFrame: Change in insulin resistance between week 0 and week 17
measure: Change in quality of life
timeFrame: Change in quality of life (as assessed by the EORTC QLQ C30 questionnaire) between week 0 and 6 months
measure: Change in grip-strength
timeFrame: Change in grip-strength between 0 weeks and 6 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
Study officials:
affiliation: Royal Surrey County Hospital NHS Trust
name: Sophie Allen, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen SK, Brown V, White D, King D, Hunt J, Wainwright J, Emery A, Hodge E, Kehinde A, Prabhu P, Rockall TA, Preston SR, Sultan J. Multimodal Prehabilitation During Neoadjuvant Therapy Prior to Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass and Quality of Life-A Pilot Randomized Clinical Trial. Ann Surg Oncol. 2022 Mar;29(3):1839-1850. doi: 10.1245/s10434-021-11002-0. Epub 2021 Nov 1.
citation: Allen S, Brown V, Prabhu P, Scott M, Rockall T, Preston S, Sultan J. A randomised controlled trial to assess whether prehabilitation improves fitness in patients undergoing neoadjuvant treatment prior to oesophagogastric cancer surgery: study protocol. BMJ Open. 2018 Dec 22;8(12):e023190. doi: 10.1136/bmjopen-2018-023190.