Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000401257
Ethics application status
Approved
Date submitted
28/04/2009
Date registered
2/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can We Alter Risk Factors For Oesophageal Cancer With Exercise?
Scientific title
A randomised controlled trial of 24 weeks of moderate-intensity exercise training versus stretching among overweight males with Barrett's oesophagus to assess the effects on biochemical and hormonal factors associated with oesophageal adenocarcinoma development.
Secondary ID [1] 259891 0
Nil
Universal Trial Number (UTN)
Trial acronym
The EPOC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett's Oesophagus 4682 0
Oesophageal Adenocarcinoma prevention 4683 0
Condition category
Condition code
Diet and Nutrition 4993 4993 0 0
Obesity
Physical Medicine / Rehabilitation 4996 4996 0 0
Physiotherapy
Cancer 237111 237111 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Moderate-intensity exercise intervention consisting of: 30 min resistance training (2 sets of 8-12 repetitions, 8 exercises including bench press, leg press, seated row, assisted chin up, assisted tricep dip, shoulder press, lunges, core stability) and 30 min of cardiovascular training (60-70% maximum heart rate, including exercise bike, treadmill). 5 sessions per week for 24 weeks. One supervised session per week performed at a hospital. Four independent sessions performed at a local private gymnasium.
Intervention code [1] 4444 0
Prevention
Intervention code [2] 4445 0
Lifestyle
Comparator / control treatment
Stretching program. 45 min sessions, 5 times per week for 24 weeks. One supervised session per week performed at a hospital. Four independent sessions performed at home.
Control group
Active

Outcomes
Primary outcome [1] 5837 0
Serum concentrations of the adipocytokines leptin and adiponectin analysed via radioimmunoassay. Blood samples will be fasting and obtained via venipuncture.
Timepoint [1] 5837 0
week 0, week 12, week 24
Primary outcome [2] 5838 0
Serum concentrations of the inflammatory cytokines: C-Reactive Protein, Tumour Necrosis Factor-Alpha and Interleukin-6 will be analysed via immunoassay from fasting blood samples, obtained via venipuncture.
Timepoint [2] 5838 0
week 0, week 12, week 24
Primary outcome [3] 5839 0
Fasting serum insulin and plasma glucose concentrations will be used to measure insulin resistance using the Quantitative Insulin Sensitivity Check Index (QUICKI) and the Reciprocal Index of Homeostasis Model Assessment (HOMA-IR) algorithms.
Timepoint [3] 5839 0
week 0, week 12, week 24
Secondary outcome [1] 241846 0
Gastro-oesophageal reflux symptoms using the Gastro-oesophageal Reflux Disease Impact Scale (GIS)
Timepoint [1] 241846 0
week 0, week 12, week 24
Secondary outcome [2] 241847 0
Bio-impedance analysis will measure body fat percentage, body fat mass and fat free mass. Waist to hip ratio and body mass index will also be measured to determine adiposity.
Timepoint [2] 241847 0
week 0, week 12, week 24
Secondary outcome [3] 241848 0
Muscular strength with be measured via the One Repetition Maximum (1RM) test performed on the bench press and leg press.
Timepoint [3] 241848 0
week 0, week 12, week 24
Secondary outcome [4] 241849 0
Peak oxygen uptake (VO2 peak) will provide a measure of cardiovascular fitness. VO2 peak will be measured via a portable metabolic analyser whilst the participant performs the Modified Shuttle Walk Test.
Timepoint [4] 241849 0
week 0, week 12, week 24

Eligibility
Key inclusion criteria
Barrett's Oesophagus confirmed via the presence of intestinal metaplasia on biopsy and an abnormal appearance of the distal oesophagus via endoscopy.
Overweight or obese (Body mass index 25-34.99kg/m2)
Performing less than 60 min of moderate-intensity exercise per week for the previous 12 weeks.
No loss or gain of >5kg of body weight during the previous 6 months.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Serious medical impairments including: heart disease, lung disease, neurological disease, uncontrolled hypertension, diabetes, cancer, orthopaedic injuries.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will complete an Expression of Interest Form. Potential participants will then be contacted by researchers who will apply the inclusion and exclusion criteria, explain the study and ask for verbal consent. Once written consent is obtained participants will enter the study and will be allocated to the 'exercise' group or the 'control' group. Allocation will be concealed using numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using a web-based randomisation program (http://www.randomization.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 1635 0
4029
Recruitment postcode(s) [2] 1636 0
4066

Funding & Sponsors
Funding source category [1] 4863 0
Government body
Name [1] 4863 0
Queensland Health - Health Practitioner Research Scheme
Country [1] 4863 0
Australia
Funding source category [2] 4864 0
Commercial sector/Industry
Name [2] 4864 0
Goodlife Health Clubs Brisbane
Country [2] 4864 0
Australia
Funding source category [3] 4865 0
University
Name [3] 4865 0
University of Queensland Sport (UQ Sport)
Country [3] 4865 0
Australia
Funding source category [4] 256666 0
Charities/Societies/Foundations
Name [4] 256666 0
The Wesley Research Institute
Country [4] 256666 0
Australia
Primary sponsor type
University
Name
Burns, Trauma and Critical Care Research Centre, School of Medicine, University of Queensland
Address
University of Queensland Centre for Clinical Research. Building 71/918, Royal Brisbane & Women's Hospital, HERSTON, Queensland 4029
Country
Australia
Secondary sponsor category [1] 4401 0
None
Name [1] 4401 0
Address [1] 4401 0
Country [1] 4401 0
Other collaborator category [1] 654 0
Hospital
Name [1] 654 0
Royal Brisbane and Women's Hospital
Address [1] 654 0
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland 4029
Country [1] 654 0
Australia
Other collaborator category [2] 655 0
Hospital
Name [2] 655 0
The Wesley Hospital
Address [2] 655 0
The Wesley Hospital. 451 Coronation Drive Auchenflower, Queensland 4066
Country [2] 655 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6925 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 6925 0
Level 7, Block 7
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland QLD 4029
Ethics committee country [1] 6925 0
Australia
Date submitted for ethics approval [1] 6925 0
Approval date [1] 6925 0
10/10/2008
Ethics approval number [1] 6925 0
2008/110
Ethics committee name [2] 6926 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 6926 0
Research and Research Training Division
Cumbrae-Stewart (Building 72)
The University of Queensland
Brisbane, 4072
Ethics committee country [2] 6926 0
Australia
Date submitted for ethics approval [2] 6926 0
Approval date [2] 6926 0
21/10/2008
Ethics approval number [2] 6926 0
2008001948
Ethics committee name [3] 6927 0
Uniting Health Care Human Research Ethics Committee
Ethics committee address [3] 6927 0
PO BOX 499
Toowong, Queensland 4066
1st Floor Moorlands House, The Wesley Hospital. 451 Coronation Drive Auchenflower QLD 4066
Ethics committee country [3] 6927 0
Australia
Date submitted for ethics approval [3] 6927 0
Approval date [3] 6927 0
09/04/2009
Ethics approval number [3] 6927 0
200913
Ethics committee name [4] 258692 0
Princess Alexandra Human Research Ethics Committee
Ethics committee address [4] 258692 0
Princess Alexandra Hospital, Ipswich Road, Wooloongabba, Queensland, 4102
Ethics committee country [4] 258692 0
Australia
Date submitted for ethics approval [4] 258692 0
Approval date [4] 258692 0
08/07/2009
Ethics approval number [4] 258692 0
HREC/09/QPAH/177
Ethics committee name [5] 258693 0
The Prince Charles Hospital Human Research & Ethics Committee
Ethics committee address [5] 258693 0
The Prince Charles Hospita, Rode Road, Chermside, Queensland, 4032
Ethics committee country [5] 258693 0
Australia
Date submitted for ethics approval [5] 258693 0
Approval date [5] 258693 0
15/12/2009
Ethics approval number [5] 258693 0
HREC/09/QPCH/204

Summary
Brief summary
Barrett’s oesophagus (BE) involves changes in the lining of the oesophagus and is a precursor for a type of oesophageal cancer. Obesity is a cause of BE and research suggests that certain hormones produced by fat tissue may be the mechanism through which obesity leads to cancer of the oesophagus.

Exercise training may be an effective intervention in reducing oesophageal cancer risk given the strong links between BE, obesity and metabolic disturbances.

There is some trial evidence that moderate-intensity exercise can improve obesity related hormone levels in overweight people without BE, but to date, no such evidence exists for patients with BE.

By randomising patients with BE to either an exercise regimen or a stretching regimen, we aim to determine whether 24 weeks of moderate-intensity exercise will lead to changes in levels of certain hormones associated with oesophageal cancer development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29540 0
Address 29540 0
Country 29540 0
Phone 29540 0
Fax 29540 0
Email 29540 0
Contact person for public queries
Name 12787 0
Brooke Winzer
Address 12787 0
Burns, Trauma & Critical Care Research Centre, Level 7, Block 6, Royal Brisbane & Women's Hospital, Butterfield Street, Queensland, 4029
Country 12787 0
Australia
Phone 12787 0
+61 7 36360973
Fax 12787 0
+61 7 33655192
Email 12787 0
[email protected]
Contact person for scientific queries
Name 3715 0
Brooke Winzer
Address 3715 0
Burns, Trauma & Critical Care Research Centre, Level 7, Block 6, Royal Brisbane & Women's Hospital, Butterfield Street, Queensland, 4029
Country 3715 0
Australia
Phone 3715 0
+61 7 36360973
Fax 3715 0
+61 7 33655192
Email 3715 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: A randomized controlled trial.2015https://dx.doi.org/10.1371/journal.pone.0117922
N.B. These documents automatically identified may not have been verified by the study sponsor.