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

NCT ID: NCT01742312

Last Updated: 2016-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-01-31

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.

Conditions

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Oesophageal Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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oesophageal adenocarcinoma

DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy

DEXA scan

Intervention Type RADIATION

all patients will undertake a full body DEXA scan before and after chemotherapy

Muscle biopsy

Intervention Type PROCEDURE

All patients will have a muscle biopsy before and after chemotherapy

cardio-pulmonary exercise testing (CPEX)

Intervention Type OTHER

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

Interventions

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DEXA scan

all patients will undertake a full body DEXA scan before and after chemotherapy

Intervention Type RADIATION

Muscle biopsy

All patients will have a muscle biopsy before and after chemotherapy

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Metastatic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Williams, MBChB, FFPMRCA, PhD

Role: STUDY_CHAIR

Graduate Entry Medical School, University of Nottingham

Locations

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Graduate Entry Medical School, University of Nottingham

Derby, Derbyshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10/H0405/38

Identifier Type: -

Identifier Source: org_study_id

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