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

February 17, 2016 updated by: University of Nottingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE33 2NE
        • Graduate Entry Medical School, University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers oesophageal cancer patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

University Hospitals of Derby and Burton NHS Foundation Trust

Investigators

  • Study Chair: John Williams, MBChB, FFPMRCA, PhD, Graduate Entry Medical School, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10/H0405/38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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