NCT01742312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

December 3, 2012

Last Update Submit

February 17, 2016

Conditions

Oesophageal Adenocarcinoma

Keywords

neoadjuvant chemotherapyoesophageal cancercardiorespiratory performance

Outcome Measures

Primary Outcomes (1)

  • muscle mass

    variations in muscle mass during neoadjuvant chemotherapy

    3 months

Secondary Outcomes (4)

  • nutritional status

    3 months

  • all cause mortality

    3 months

  • mitochondrial function performance status

    3 months

  • cardiorespiratory performance (peak VO2)

    3 months

Study Arms (1)

oesophageal adenocarcinoma

DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy

Radiation: DEXA scanProcedure: Muscle biopsyOther: cardio-pulmonary exercise testing (CPEX)

Interventions

DEXA scanRADIATION

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

oesophageal adenocarcinoma
Muscle biopsyPROCEDURE

All patients will have a muscle biopsy before and after chemotherapy

oesophageal adenocarcinoma
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

oesophageal adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers oesophageal cancer patients

You may qualify if:

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

You may not qualify if:

  • Metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Entry Medical School, University of Nottingham

Derby, Derbyshire, DE33 2NE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood tests for serum albumin and total protien levels.

MeSH Terms

Conditions

Adenocarcinoma Of EsophagusEsophageal Neoplasms

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • John Williams, MBChB, FFPMRCA, PhD

    Graduate Entry Medical School, University of Nottingham

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 5, 2012

Study Start

October 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

GB(1)