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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01742312
Acronym
Oeso-Chemo
Enrollment
25
Registered
2012-12-05
Start date
2011-10-31
Completion date
2013-01-31
Last updated
2016-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal Adenocarcinoma

Keywords

neoadjuvant chemotherapy, oesophageal cancer, cardiorespiratory performance

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.

Interventions

RADIATIONDEXA scan

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

PROCEDUREMuscle biopsy

All patients will have a muscle biopsy before and after chemotherapy

OTHERcardio-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

Sponsors

University Hospitals of Derby and Burton NHS Foundation Trust
CollaboratorOTHER
University of Nottingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Metastatic disease

Design outcomes

Primary

MeasureTime frameDescription
muscle mass3 monthsvariations in muscle mass during neoadjuvant chemotherapy

Secondary

MeasureTime frameDescription
nutritional status3 monthsassess nutritional status post chemotherapy via serum protein levels.
all cause mortality3 monthsEvidence of mortality and relate this to aerobic ability.
mitochondrial function performance status3 monthsreview changes in mitochondrial function after neoadjuvant chemotherapy
cardiorespiratory performance (peak VO2)3 monthsreview changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026