Abstract
ObjectiveTo investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett’s oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development.MethodsA randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions) versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions) in inactive, overweight/obese (25.0–34.9 kg/m2) males with Barrett’s oesophagus, aged 18–70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]). Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value.ResultsRecruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80); 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control) was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01). Effects on primary outcomes were not statistically significant.ConclusionThis small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this population and relax inclusion criteria to maximize recruitment.Trial RegistrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000401257
Highlights
During the past three decades, the incidence of oesophageal adenocarcinoma has risen by over 300% in females and 500% in males in Western countries [1,2,3,4,5]
Effects on primary outcomes were not statistically significant. This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk
If Barrett’s oesophagus does progress to adenocarcinoma, prognosis is poor with a 5-year survival rate of 10–15%, despite surgery and chemotherapy [10,11]
Summary
During the past three decades, the incidence of oesophageal adenocarcinoma has risen by over 300% in females and 500% in males in Western countries [1,2,3,4,5]. The incidence of the precursor lesion, Barrett’s oesophagus is rising rapidly [6,7]. People diagnosed with Barrett’s oesophagus have an oesophageal adenocarcinoma risk of approximately 30–40 times higher than that of a healthy population [8,9]. If Barrett’s oesophagus does progress to adenocarcinoma, prognosis is poor with a 5-year survival rate of 10–15%, despite surgery and chemotherapy [10,11]. At present there is limited evidence regarding lifestyle interventions aimed at reducing cancer risk in males with Barrett’s oesophagus [12]
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