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

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02950324
• Other study ID #: 16/LO/1702
• Status: Not yet recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: October 27, 2016
• Start date: November 2016
• Est. completion date: November 2022

Study information

• Verified date: October 2016
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: Sophie Allen, MBBCh
• Phone: 07733 258752
• Email: sophieallen[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2022
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Insulin Resistance
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiopulmonary exercise performance		Change in cardiopulmonary exercise performance between week 0 and week 17	No
Secondary	Change in insulin resistance		Change in insulin resistance between week 0 and week 17	No
Secondary	Change in quality of life		Change in quality of life (as assessed by the EORTC QLQ C30 questionnaire) between week 0 and 6 months	No
Secondary	Change in grip-strength		Change in grip-strength between 0 weeks and 6 months	No