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.
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?'
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom
RECRUITINGRecruitment rate
Defined as the proportion of all patients approached that agree to enter the study.
Time frame: 1 year
Completion rate
Defined as the proportion of all patients that enter the study that remain participants at the end of the defined study period (at surgery).
Time frame: 1 year
Individual compliance
With the intervention, defined as the percentage of intervention days when the patient was wearing his/her pedometer, was contactable every week and was recording his/her daily step count.
Time frame: 1 year
CPET measurements
Cardiopulmonary fitness measured by cardiopulmonary exercise testing.
Time frame: 1 year
Sarcopenia
Change in amount of L3 level skeletal muscle area
Time frame: 1 year
Sarcopenia
Change in grip strength
Time frame: 1 year
Step count
Change in daily step count from pedometer each day
Time frame: 1 year
Quality of life
Quality of life using QLQ-C30 and QLQ-OG25 questionnaires
Time frame: 1 year
End of study questionnaire
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Subjective perception of intervention using questionnaire
Time frame: 1 year
Focus group
End of study 'PPI' focus group to assess exercise intervention
Time frame: 1 year
Outcome of oncology treatment
Percentage of planned chemotherapy delivered
Time frame: 1 year
Outcome of oncology treatment
Number of patients with dose reductions or who terminate chemotherapy early
Time frame: 1 year
Outcome of oncology treatment
Admissions to hospital with chemotherapy induced toxicity
Time frame: 1 year