Exercise and the prevention of oesophageal cancer (EPOC) study protocol: A randomized controlled trial of exercise versus stretching in males with Barrett's oesophagus

Winzer, Brooke M., Paratz, Jennifer D., Reeves, Marina M. and Whiteman, David C. (2010) Exercise and the prevention of oesophageal cancer (EPOC) study protocol: A randomized controlled trial of exercise versus stretching in males with Barrett's oesophagus. BMC Cancer, 10 Article # 292: 1-7. doi:10.1186/1471-2407-10-292


Author Winzer, Brooke M.
Paratz, Jennifer D.
Reeves, Marina M.
Whiteman, David C.
Title Exercise and the prevention of oesophageal cancer (EPOC) study protocol: A randomized controlled trial of exercise versus stretching in males with Barrett's oesophagus
Journal name BMC Cancer   Check publisher's open access policy
ISSN 1471-2407
Publication date 2010-06
Sub-type Article (original research)
DOI 10.1186/1471-2407-10-292
Open Access Status DOI
Volume 10
Issue Article # 292
Start page 1
End page 7
Total pages 8
Place of publication London
Publisher BioMed Central
Language eng
Subject 1112 Oncology and Carcinogenesis
Formatted abstract
Background:
Chronic gastro-oesophageal reflux disease and excessive body fat are considered principal causes of Barrett's oesophagus (a metaplastic change in the cells lining the oesophagus) and its neoplastic progression, oesophageal adenocarcinoma. Metabolic disturbances including altered levels of obesity-related cytokines, chronic inflammation and insulin resistance have also been associated with oesophageal cancer development, especially in males. Physical activity may have the potential to abrogate metabolic disturbances in males with Barrett's oesophagus and elicit beneficial reductions in body fat and gastro-oesophageal reflux symptoms. Thus, exercise may be an effective intervention in reducing oesophageal adenocarcinoma risk. However, to date this hypothesis remains untested.
The 'Exercise and the Prevention of Oesophageal Cancer Study' will determine whether 24 weeks of exercise training will lead to alterations in risk factors or biomarkers for oesophageal adenocarcinoma in males with Barrett's oesophagus. Our primary outcomes are serum concentrations of leptin, adiponectin, tumour necrosis factor-alpha, Creactive protein and interleukin-6 as well as insulin resistance. Body composition, gastro-oesophageal reflux disease symptoms, cardiovascular fitness and muscular strength will also be assessed as secondary outcomes.

Methods/Design:
A randomized controlled trial of 80 overweight or obese, inactive males with Barrett's oesophagus will be conducted in Brisbane, Australia. Participants will be randomized to an intervention arm (60 minutes of moderate-intensity aerobic and resistance training, five days per week) or a control arm (45 minutes of stretching, five days per week) for 24 weeks. Primary and secondary endpoints will be measured at baseline (week 0), midpoint (week 12) and at the end of the intervention (week 24).

Discussion:
Due to the increasing incidence and very high mortality associated with oesophageal adenocarcinoma, interventions effective in preventing the progression of Barrett's oesophagus are urgently needed. We propose that exercise may be successful in reducing oesophageal adenocarcinoma risk. This primary prevention trial will also provide information on whether the protective association between physical activity and cancer is causal.

Trial Registration:
ACTRN12609000401257 © 2010 Winzer et al; licensee BioMed Central Ltd.
Keyword Gastroesophageal-reflux Disease
C-reactive protein
Postmenopausal Women
Clinical-trial
Physical-activity
Leptin Levels
Insulin Sensitivity
Rising Incidence
Histologic Types
Plasma Leptin
Q-Index Code CX
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Received: 14 April 2010 Accepted: 16 June 2010 Published: 16 June 2010

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
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Created: Sun, 15 Aug 2010, 00:06:56 EST