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

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Unknown

Conditions: Esophageal Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Other: ChemoFit exercise prehabilitation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04194463

09041

Details and patient eligibility

About

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.

Full 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?'

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ChemoFit exercise prehabilitation intervention

Experimental group

Description:

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.

Treatment:

Other: ChemoFit exercise prehabilitation intervention