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

Study Overview
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Brief Summary
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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
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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?'

Official Title
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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)

Conditions
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Esophageal Adenocarcinoma, Gastric Adenocarcinoma

Intervention / Treatment
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* Other: ChemoFit exercise prehabilitation intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Operable adenocarcinoma of the oesophagus, oesophago-gastric junction and stomach (locally advanced adenocarcinoma with planned preoperative chemotherapy, T3+, T1/2 N+) Planned preoperative chemotherapy with ECX, ECX variant or FLOT chemotherapy Age >18 Ability to complete CPET Ability to consent to study and carry out the planned intervention. Exclusion Criteria: Standard contraindications to CPET testing as defined by ATS Guidance Orthopaedic limitations to CPET and / or daily exercise, for example, amputation, severe knee or hip disease. Inoperable cancer at initial screening MDT Planned non-surgical treatment with either radiotherapy or combined chemoradiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ChemoFit exercise prehabilitation intervention<br>Exercise intervention consisting of walking and increasing daily step count. This is monitored by wearing a pedometer device. Other part of intervention are 5 simple strengthening exercises. | Other: ChemoFit exercise prehabilitation intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Defined as the proportion of all patients approached that agree to enter the study. | 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). | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPET measurements | Cardiopulmonary fitness measured by cardiopulmonary exercise testing. | 1 year | 
| Sarcopenia | Change in amount of L3 level skeletal muscle area | 1 year | 
| Sarcopenia | Change in grip strength | 1 year | 
| Step count | Change in daily step count from pedometer each day | 1 year | 
| Quality of life | Quality of life using QLQ-C30 and QLQ-OG25 questionnaires | 1 year | 
| End of study questionnaire | Subjective perception of intervention using questionnaire | 1 year | 
| Focus group | End of study 'PPI' focus group to assess exercise intervention | 1 year | 
| Outcome of oncology treatment | Percentage of planned chemotherapy delivered | 1 year | 
| Outcome of oncology treatment | Number of patients with dose reductions or who terminate chemotherapy early | 1 year | 
| Outcome of oncology treatment | Admissions to hospital with chemotherapy induced toxicity | 1 year |