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Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer. (Oeso-Chemo)

This study has been completed.
Derby Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University of Nottingham Identifier:
First received: December 3, 2012
Last updated: February 17, 2016
Last verified: February 2016
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.

Condition Intervention
Oesophageal Adenocarcinoma
Radiation: DEXA scan
Procedure: Muscle biopsy
Other: cardio-pulmonary exercise testing (CPEX)

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • muscle mass [ Time Frame: 3 months ]
    variations in muscle mass during neoadjuvant chemotherapy

Secondary Outcome Measures:
  • nutritional status [ Time Frame: 3 months ]
    assess nutritional status post chemotherapy via serum protein levels.

  • all cause mortality [ Time Frame: 3 months ]
    Evidence of mortality and relate this to aerobic ability.

  • mitochondrial function performance status [ Time Frame: 3 months ]
    review changes in mitochondrial function after neoadjuvant chemotherapy

  • cardiorespiratory performance (peak VO2) [ Time Frame: 3 months ]
    review changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy

Biospecimen Retention:   Samples Without DNA
blood tests for serum albumin and total protien levels.

Enrollment: 25
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
oesophageal adenocarcinoma
DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy
Radiation: DEXA scan
all patients will undertake a full body DEXA scan before and after chemotherapy
Procedure: Muscle biopsy
All patients will have a muscle biopsy before and after chemotherapy
Other: 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

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers oesophageal cancer patients

Inclusion Criteria:

  • oesophageal cancer
  • Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery

Exclusion Criteria:

  • Metastatic disease
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Please refer to this study by its identifier: NCT01742312

United Kingdom
Graduate Entry Medical School, University of Nottingham
Derby, Derbyshire, United Kingdom, DE33 2NE
Sponsors and Collaborators
University of Nottingham
Derby Hospitals NHS Foundation Trust
Study Chair: John Williams, MBChB, FFPMRCA, PhD Graduate Entry Medical School, University of Nottingham
  More Information

Responsible Party: University of Nottingham Identifier: NCT01742312     History of Changes
Other Study ID Numbers: 10/H0405/38
Study First Received: December 3, 2012
Last Updated: February 17, 2016

Keywords provided by University of Nottingham:
neoadjuvant chemotherapy
oesophageal cancer
cardiorespiratory performance

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on April 21, 2017