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

Last updated: March 11, 2020
Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stomach Cancer

Gastric Cancer

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT04194463
09041
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 40
Study Start date:
February 28, 2019
Estimated Completion Date:
June 30, 2020

Study 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?'

Connect with a study center

  • Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle Upon Tyne, Tyne And Wear NE1 4LP
    United Kingdom

    Active - Recruiting

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