Oesophagogastric adenocarcinoma Cancer
Conditions
Interventions
This study is a single centre, pilot, randomised control trial. Eligible patients from Salford Royal Hospital will be consulted and informed about the trial and if they consent will be randomised to e
Sponsors
Northern Care Alliance NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old or older with locally advanced oesophageal, gastric or junctional adenocarcinoma (T2 N1 or above on initial composite staging) 2. Curative treatment pathway with neoadjuvant chemotherapy followed by surgery 3. Oesophagectomy by any approach including trial dissections or abandoned oesophagectomy. Gastrectomy by any approach including trial dissections or abandoned surgery. 4. WHO performance status </= 2
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma 2. Palliative treatment pathway or development of unresectable disease during neoadjuvant treatment. 3. Treatment for recurrent oesophageal cancer or salvage treatment. 4. Synchronous malignancy elsewhere 5. Medically deemed unable to partake in resistance training program or study assessments due to significant musculoskeletal or mobility comorbidity. 6. Established neuromuscular diagnosis (inflammatory myopathy, idiopathic myositis) 7. Pregnancy 8. Unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of sarcopenia – lean muscle mass measured using Ultrasound of vastus lateralis at Baseline (0 weeks) , post completion of neoadjuvant chemotherapy (approx 8 weeks) and prior to surgery (approx 16 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscle strength (isometric hand grip strength and knee extensor strength) measured using Hand grip dynamometry and knee extensor strength test at Baseline, after chemotherapy, 1 to 2 weeks before surgery;Mitochondrial function measured using Muscle biopsy using Orobouros analysis and 31P magnetic resonance spectroscopy (MRI spectroscopy) assessing Pi magnetisation transfer at rest and phosphocreatine depletion and repletion kinetics during and after exercise at diagnostic laparoscopy, at resection surgery;Cardiovascular fitness measured using Cardiopulmonary exercise test (CPET) and short physical performance battery (SPPB) at Baseline, after chemotherapy, 1 to 2 weeks before surgery;Muscle morphology (fibre cross sectional area, fibre type distribution, capillary to fibre ratio, mitochondrial enzyme activity) measured using Histological analysis of muscle biopsy samples including succinate dehydrogenase staining at staging laparoscopy, at resection surgery;Muscle vascularity measured using Magnetic resonance imaging using arterial spin labelling and functional MRI sequences at rest and during exercise at Baseline, after chemotherapy, 1 to 2 weeks before surgery;Blood biomarkers (full blood count parameters, albumin, haematocrit, cytokines) measured using Laboratory analysis of blood samples at baseline (0 weeks) , post completion of neoadjuvant chemotherapy (approx 8 weeks) and prior to surgery (approx 16 weeks);Completion of chemotherapy treatment (dose reduction, missed doses, treatment abandonment, surgical candidacy status) measured using Clinical records and treatment logs at During neoadjuvant chemotherapy, during adjuvant chemotherapy;Health related quality of life measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and OG25 modules at Throughout research period;Nutritional status and requirements measured using Estimation using standard formulae and physical activity level assessment using information | — |
Countries
England, United Kingdom
Contacts
Public ContactJennifer Redfern
Outcome results
None listed