Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer. (Oeso-Chemo)
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.
Radiation: DEXA scan
Procedure: Muscle biopsy
Other: cardio-pulmonary exercise testing (CPEX)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effect of Neoadjuvant Chemotherapy on Muscle Mass and Peri-operative Cardiorespiratory Performance in Patients Undergoing Oesophageal Cancer- a Pilot Study|
- muscle mass [ Time Frame: 3 months ] [ Designated as safety issue: No ]variations in muscle mass during neoadjuvant chemotherapy
- nutritional status [ Time Frame: 3 months ] [ Designated as safety issue: No ]assess nutritional status post chemotherapy via serum protein levels.
- all cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]Evidence of mortality and relate this to aerobic ability.
- mitochondrial function performance status [ Time Frame: 3 months ] [ Designated as safety issue: No ]review changes in mitochondrial function after neoadjuvant chemotherapy
- cardiorespiratory performance (peak VO2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]review changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy
Biospecimen Retention: Samples Without DNA
blood tests for serum albumin and total protien levels.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy
Radiation: DEXA scan
all patients will undertake a full body DEXA scan before and after chemotherapyProcedure: Muscle biopsy
All patients will have a muscle biopsy before and after chemotherapyOther: cardio-pulmonary exercise testing (CPEX)
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742312
|Contact: John Williams, MBChB, FFPMRCA, PhDfirstname.lastname@example.org|
|Graduate Entry Medical School, University of Nottingham||Recruiting|
|Derby, Derbyshire, United Kingdom, DE33 2NE|
|Study Chair:||John Williams, MBChB, FFPMRCA, PhD||Graduate Entry Medical School, University of Nottingham|