Adenocarcinoma of oesophagus or stomach Cancer Adenocarcinoma of oesophagus or stomach
Conditions
Interventions
Eligible patients for the study are identified at MDM and are approached at the next available oncology clinic at which point an Information leaflet is disseminated to interested patients. Twenty four
TGUG as well as questionnaires) (study data collected as part of the study and anonymised ) this is performed at 0-7 days post completion of NAC.
Second post NAC set of data is colle
TGUG as well as questionnaires) (study data collected as part of the study and anonymised). Third post NAC set of data is collected at 28-35 days post completion of NAC (CPET
TGUG as well as questionnaires) (study data collected as part of the study and anonymised). The proposed surgical intervention is then carried out. The clinical team are blinded to the outcome of the
Sponsors
Royal Victoria Infirmary
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of adenocarcinoma of the oesophagus or stomach 2. Patients deemed suitable for neo-adjuvant chemotherapy prior to resectional surgery 3. Absolute or relative contraindication in the patient’s ability to perform serial (cardiopulmonary exercise tests) CPETs 4. Written informed consent 5. Aged 18 years and over
Exclusion criteria
Exclusion criteria: 1. A pathological diagnosis other than adenocarcinoma. 2. Inability to consent or withdrawal of consent at any point during the research process 3.Absolute or relative contraindication to CPET testing: 3.1. Absolute: 3.1.1. Acute myocardial infarction (3–5 days) 3.1.2. Unstable angina 3.1.3. Uncontrolled arrhythmias causing symptoms or haemodynamic compromise 3.1.4. Syncope 3.1.5. Active endocarditis 3.1.6. Acute myocarditis or pericarditis 3.1.7. Symptomatic severe aortic stenosis 3.1.8. Uncontrolled heart failure 3.1.9. Acute pulmonary embolus or pulmonary infarction 3.1.10. Thrombosis of lower extremities 3.1.11. Suspected dissecting aneurysm 3.1.12. Uncontrolled asthma 3.1.13. Pulmonary oedema 3.1.14. Room air desaturation at rest 85%* 3.1.15. Respiratory failure 3.1.16. Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (ie, infection, renal failure, thyrotoxicosis) 3.1.17. Mental impairment leading to inability to cooperate 3.2. Relative: 3.2.1. Left main coronary stenosis or its equivalent 3.2.2. Moderate stenotic valvular heart disease 3.2.3. Severe untreated arterial hypertension at rest or haemodynamic compromise (>200 mm Hg systolic, >120 mm Hg diastolic) 3.2.4. Tachyarrhythmias or bradyarrhythmias 3.2.5. High-degree atrioventricular block 3.2.6. Hypertrophic cardiomyopathy 3.2.7. Significant pulmonary hypertension 3.2.8. Advanced or complicated pregnancy 3.2.9. Electrolyte abnormalities 3.2.10. Orthopaedic impairment that compromises exercise performance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of net-adjuvant chemotherapy on cardiorespiratory fitness in patients with oesophagogastric adenocarcinoma is measured using Cardiopulmonary Exercise Testing (CPET) immediately following chemotherapy (baseline) and before surgery (at 0 weeks, 2 weeks and 4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective measurement of changes and restoration of fitness after chemotherapy in order to optimise timing of surgery 2. Impact of NAC on quality of life indices using The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in combination with Oesophago-gastric Questionnaire (EORTC QLQ-OG25) before chemotherapy at 0 weeks post chemotherapy and at 4 weeks post chemotherapy prior to surgery 3. Impact of NAC on nutritional status is measured using the Mini Nutritional Assessment questionnaire (MNA) before chemotherapy at 0 weeks post chemotherapy and at 4 weeks post chemotherapy prior to surgery 4. Impact of NAC on sarcopenia is assessed by measuring the following: 4.1. Muscle mass is measured using CT scans pre and post chemotherapy performed as part of routine clinical care 4.2. Muscle strength – Grip strength is measured using a hydraulic hand dynameter before chemotherapy at 0 weeks post chemotherapy and at 4 weeks post chemotherapy prior to surgery 4.3. Muscle Function is measured using the Timed Get up and Go test (TGUG) before chemotherapy at 0 weeks post chemotherapy and at 4 weeks post chemotherapy prior to surgery | — |
Countries
United Kingdom
Outcome results
None listed