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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Nottingham
Sponsor:
Collaborator:
Derby Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01742312
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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 Intervention
Oesophageal Adenocarcinoma
Radiation: DEXA scan
Procedure: Muscle biopsy
Other: cardio-pulmonary exercise testing (CPEX)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • muscle mass [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    variations in muscle mass during neoadjuvant chemotherapy


Secondary Outcome Measures:
  • nutritional status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    assess nutritional status post chemotherapy via serum protein levels.

  • all cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evidence of mortality and relate this to aerobic ability.

  • mitochondrial function performance status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    review changes in mitochondrial function after neoadjuvant chemotherapy

  • cardiorespiratory performance (peak VO2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    review changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy


Biospecimen Retention:   Samples Without DNA

blood tests for serum albumin and total protien levels.


Estimated Enrollment: 25
Study Start Date: October 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteers oesophageal cancer patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Metastatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742312

Contacts
Contact: John Williams, MBChB, FFPMRCA, PhD 01332786086 john.williams7@nhs.net

Locations
United Kingdom
Graduate Entry Medical School, University of Nottingham Recruiting
Derby, Derbyshire, United Kingdom, DE33 2NE
Sponsors and Collaborators
University of Nottingham
Derby Hospitals NHS Foundation Trust
Investigators
Study Chair: John Williams, MBChB, FFPMRCA, PhD Graduate Entry Medical School, University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01742312     History of Changes
Other Study ID Numbers: 10/H0405/38
Study First Received: December 3, 2012
Last Updated: December 4, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
neoadjuvant chemotherapy
oesophageal cancer
cardiorespiratory performance

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 15, 2014