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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2020-06-30

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.

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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?'

Conditions

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Esophageal Adenocarcinoma Gastric Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ChemoFit exercise prehabilitation intervention

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.

Group Type EXPERIMENTAL

ChemoFit exercise prehabilitation intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No