Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer.

Study Overview
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Brief Summary
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Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.

Detailed Description
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We aim to review the effects of chemotherapy on skeletal muscle mass and cardio-respiratory performance in patients with oesophageal adenocarcinoma. All patients will be assessed by a Consultant Anaesthetist and a medical member of the Research team before commencing chemotherapy and after finishing their course. These assessments include a nutritional assessment, performance status assessments, blood assays, dual energy X-ray absorptiometry (DEXA) scans, cardio-pulmonary exercise (CPEX) testing and a muscle biopsy.

Official Title
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Effect of Neoadjuvant Chemotherapy on Muscle Mass and Peri-operative Cardiorespiratory Performance in Patients Undergoing Oesophageal Cancer- a Pilot Study

Conditions
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Oesophageal Adenocarcinoma

Intervention / Treatment
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* Radiation: DEXA scan
* Procedure: Muscle biopsy
* Other: cardio-pulmonary exercise testing (CPEX)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: oesophageal cancer Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery Exclusion Criteria: Metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| oesophageal adenocarcinoma<br>DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy | Radiation: DEXA scan<br>* all patients will undertake a full body DEXA scan before and after chemotherapy<br>Procedure: Muscle biopsy<br>* All patients will have a muscle biopsy before and after chemotherapy<br>Other: cardio-pulmonary exercise testing (CPEX)<br>* patients will undertake exercise in the form of an exercise bike whilst having their cardiac and ventilatory performance analysed. This will take place before and after neoadjuvant chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass | variations in muscle mass during neoadjuvant chemotherapy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional status | assess nutritional status post chemotherapy via serum protein levels. | 3 months | 
| all cause mortality | Evidence of mortality and relate this to aerobic ability. | 3 months | 
| mitochondrial function performance status | review changes in mitochondrial function after neoadjuvant chemotherapy | 3 months | 
| cardiorespiratory performance (peak VO2) | review changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant chemotherapy, oesophageal cancer, cardiorespiratory performance