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

Completed

• Conditions: Oesophageal Adenocarcinoma
• Interventions: Radiation: DEXA scan; Procedure: Muscle biopsy; Other: cardio-pulmonary exercise testing (CPEX)

• Registration Number: NCT01742312
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

• Metastatic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oesophageal adenocarcinoma	cardio-pulmonary exercise testing (CPEX)	DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy
oesophageal adenocarcinoma	DEXA scan	DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy
oesophageal adenocarcinoma	Muscle biopsy	DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy

Primary Outcome Measures

Name	Time	Method
muscle mass	3 months	variations in muscle mass during neoadjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
all cause mortality	3 months	Evidence of mortality and relate this to aerobic ability.
nutritional status	3 months	assess nutritional status post chemotherapy via serum protein levels.
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

Trial Locations

Locations (1)

Graduate Entry Medical School, University of Nottingham; 🇬🇧 Derby, Derbyshire, United Kingdom