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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742312
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : February 18, 2016
University Hospitals of Derby and Burton NHS Foundation Trust
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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 or disease Intervention/treatment
Oesophageal Adenocarcinoma Radiation: DEXA scan Procedure: Muscle biopsy Other: cardio-pulmonary exercise testing (CPEX)

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.

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Study Type : Observational
Actual Enrollment : 25 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

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

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

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

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

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742312

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United Kingdom
Graduate Entry Medical School, University of Nottingham
Derby, Derbyshire, United Kingdom, DE33 2NE
Sponsors and Collaborators
University of Nottingham
University Hospitals of Derby and Burton NHS Foundation Trust
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Study Chair: John Williams, MBChB, FFPMRCA, PhD Graduate Entry Medical School, University of Nottingham
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Responsible Party: University of Nottingham Identifier: NCT01742312    
Other Study ID Numbers: 10/H0405/38
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Keywords provided by University of Nottingham:
neoadjuvant chemotherapy
oesophageal cancer
cardiorespiratory performance