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NCT Number: NCT01742312

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

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.

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Key information

Conditions

Oesophageal Adenocarcinoma Adenocarcinoma Of Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Graduate Entry Medical School, University of Nottingham

Derby, Derbyshire, DE33 2NE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Metastatic disease

Treatment and study plan

DEXA Scan

Radiation

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

Muscle biopsy

Procedure

All patients will have a muscle biopsy before and after chemotherapy

cardio-pulmonary exercise testing (CPEX)

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

Primary outcomes

  1. muscle mass

    Time frame: 3 months

    variations in muscle mass during neoadjuvant chemotherapy

Secondary outcomes

  1. nutritional status

    Time frame: 3 months

    assess nutritional status post chemotherapy via serum protein levels.

  2. all cause mortality

    Time frame: 3 months

    Evidence of mortality and relate this to aerobic ability.

  3. mitochondrial function performance status

    Time frame: 3 months

    review changes in mitochondrial function after neoadjuvant chemotherapy

  4. cardiorespiratory performance (peak VO2)

    Time frame: 3 months

    review changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

Registry information

Official study title

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

Acronym: Oeso-Chemo

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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