Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study
- Conditions
- Esophageal AdenocarcinomaGastric Adenocarcinoma
- Interventions
- Other: ChemoFit exercise prehabilitation intervention
- Registration Number
- NCT04194463
- Lead Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Brief 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.
- Detailed 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?'
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ChemoFit exercise prehabilitation intervention 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.
- Primary Outcome Measures
Name Time Method Recruitment rate 1 year Defined as the proportion of all patients approached that agree to enter the study.
Individual compliance 1 year 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.
Completion rate 1 year Defined as the proportion of all patients that enter the study that remain participants at the end of the defined study period (at surgery).
- Secondary Outcome Measures
Name Time Method Sarcopenia 1 year Change in grip strength
Outcome of oncology treatment 1 year Admissions to hospital with chemotherapy induced toxicity
Step count 1 year Change in daily step count from pedometer each day
Quality of life 1 year Quality of life using QLQ-C30 and QLQ-OG25 questionnaires
CPET measurements 1 year Cardiopulmonary fitness measured by cardiopulmonary exercise testing.
End of study questionnaire 1 year Subjective perception of intervention using questionnaire
Focus group 1 year End of study 'PPI' focus group to assess exercise intervention
Trial Locations
- Locations (1)
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom