NCT04194463

Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study

Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study to Design and Investigate the Utility of a Simple, Home-Based, Exercise Intervention During Chemotherapy. (ChemoFit)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Feasibility study to investigate the utility of a simple, home-based, exercise intervention during and after neo-adjuvant chemotherapy but prior to surgery for esophageal and gastric adenocarcinoma.

Detailed description

The principle aim of this study is to test the feasibility of utilising a home-based 'prehabilitation' exercise regimen in oesophago-gastric patients during preoperative chemotherapy and the period leading up to surgical resection. The investigators also hope to explore secondary outcomes of such a regimen, such as maintenance of fitness, the incidence of sarcopenia, muscle function and the outcomes of therapy. The investigators will explore the added value of blood-borne frailty biomarkers to objectively measure changes in physiology during neo-adjuvant chemotherapy (NAC). This will be tested using CPET, CT measured sarcopenia, grip strength and a small panel of biomarkers as secondary outcome and exploratory measures. Thus the main question is: 'Will patients participate in a home-based exercise programme during and after NAC for oesophago-gastric cancer?'

Conditions

• Esophageal Adenocarcinoma
• Gastric Adenocarcinoma

Interventions

Type	Name	Description
OTHER	ChemoFit exercise prehabilitation intervention	Exercise intervention consists of walking monitored by wearing a pedometer device. After a baseline measurement of participant's walking activity is done, increase in step count from baseline step count is prescribed. This increase in step count is achieved by walking or jogging at moderate intensity for a target of 30 minutes per day, each day. Participants are also encouraged to perform other physical if they wish and are able to. Patients are regularly contacted by a member of the research team on a weekly basis and given an option to maintain or to increase their step count further. The same approach is used after each week of the intervention. Strengthening exercises will form a further part of the exercise intervention. They are performed every day, 7 days a week. Patients are supplied with resistance bands with handles. They are educated on how to perform two repetitions of 5 simple exercises, each for 1 minute duration.

Timeline

• Start date: 2019-02-28
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-12-11
• Last updated: 2020-03-12

Locations

1 site across 1 country: United Kingdom