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

Sponsor

University of Nottingham (Other)

Overall Status

Completed

CT.gov ID

NCT01742312

Collaborator

University Hospitals of Derby and Burton NHS Foundation Trust (Other)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Oct 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

muscle mass [3 months]
variations in muscle mass during neoadjuvant chemotherapy

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Metastatic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Nottingham

ClinicalTrials.gov Identifier:

NCT01742312

Other Study ID Numbers:

10/H0405/38

First Posted:

Dec 5, 2012

Last Update Posted:

Feb 18, 2016

Last Verified:

Feb 1, 2016

Keywords provided by University of Nottingham

neoadjuvant chemotherapy

oesophageal cancer

cardiorespiratory performance

Study Results

No Results Posted as of Feb 18, 2016