Impact of chemotherapy on fitness before surgery on patients with cancer of oesophagus and stomach

Not Applicable

Completed

• Conditions: Adenocarcinoma of oesophagus or stomach; Cancer

• Registration Number: ISRCTN44343129
• Lead Sponsor: Royal Victoria Infirmary

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29601082 (added 24/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-08
• Study Completion: 2017-10-01
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)