Abstract
Background:Polyphenol-rich foods such as pomegranate, green tea, broccoli and turmeric have demonstrated anti-neoplastic effects in laboratory models involving angiogenesis, apoptosis and proliferation. Although some have been investigated in small, phase II studies, this combination has never been evaluated within an adequately powered randomised controlled trial.Methods:In total, 199 men, average age 74 years, with localised prostate cancer, 60% managed with primary active surveillance (AS) or 40% with watchful waiting (WW) following previous interventions, were randomised (2:1) to receive an oral capsule containing a blend of pomegranate, green tea, broccoli and turmeric, or an identical placebo for 6 months.Results:The median rise in PSA in the food supplement group (FSG) was 14.7% (95% confidence intervals (CIs) 3.4–36.7%), as opposed to 78.5% in the placebo group (PG) (95% CI 48.1–115.5%), difference 63.8% (P=0.0008). In all, 8.2% of men in the FSG and 27.7% in the PG opted to leave surveillance at the end of the intervention (χ2 P=0.014). There were no significant differences within the predetermined subgroups of age, Gleason grade, treatment category or body mass index. There were no differences in cholesterol, blood pressure, blood sugar, C-reactive protein or adverse events.Conclusions:This study found a significant short-term, favourable effect on the percentage rise in PSA in men managed with AS and WW following ingestion of this well-tolerated, specific blend of concentrated foods. Its influence on decision-making suggests that this intervention is clinically meaningful, but further trials will evaluate longer term clinical effects, and other makers of disease progression.
Highlights
Diets deficient in polyphenols and other natural plant-based phytochemicals found in herbs, spices, fruit, teas, colourful vegetables and other healthy plant-based foods, have been linked with higher risks of cancer breast,[1,2] pancreas,[3] ovary,[4] skin,[5] prostate,[6,7] bowel[8] and oesophagus.[9]The protective benefits of polyphenols, do not to stop after a diagnosis of cancer
This was a placebo-controlled, double-blind, randomised trial designed with the aim of establishing whether supplementing the diet with a polyphenol-rich, whole food supplement containing a blend of green tea, pomegranate, broccoli and curcumin influenced the rate of PSA progression, compared with placebo among men with prostate cancer either managed with primary active surveillance (AS) or watchful waiting (WW), following a PSA relapse postradical treatments
Statistical methods The percentage change in PSA from baseline to final measurement was evaluated using an analysis of covariance (ANCOVA) which assessed the effect of the food supplement group (FSG) versus placebo group (PG), as well as the predetermined subgroups of Gleason grade, body mass index and treatment category
Summary
Diets deficient in polyphenols and other natural plant-based phytochemicals found in herbs, spices, fruit, teas, colourful vegetables and other healthy plant-based foods, have been linked with higher risks of cancer breast,[1,2] pancreas,[3] ovary,[4] skin,[5] prostate,[6,7] bowel[8] and oesophagus.[9]The protective benefits of polyphenols, do not to stop after a diagnosis of cancer. METHODS: In total, 199 men, average age 74 years, with localised prostate cancer, 60% managed with primary active surveillance (AS) or 40% with watchful waiting (WW) following previous interventions, were randomised (2:1) to receive an oral capsule containing a blend of pomegranate, green tea, broccoli and turmeric, or an identical placebo for 6 months. CONCLUSIONS: This study found a significant short-term, favourable effect on the percentage rise in PSA in men managed with AS and WW following ingestion of this well-tolerated, specific blend of concentrated foods. Its influence on decision-making suggests that this intervention is clinically meaningful, but further trials will evaluate longer term clinical effects, and other makers of disease progression
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