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A double-blind, placebo-controlled randomised trial evaluating the effect of a polyphenol-rich whole food supplement on PSA progression in men with prostate cancer--the U.K. NCRN Pomi-T study.

Thomas R, Williams M, Sharma H, Chaudry A, Bellamy P - Prostate Cancer Prostatic Dis. (2014)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: 1] The Primrose Research Unit, Bedford Hospital, Bedford, UK [2] Department of Oncology, Addenbrooke's Cambridge University NHS Trust, Cambridge, UK [3] Department of Postgraduate Medicine, Cranfield University, Cranfield, UK.

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.

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Related in: MedlinePlus

Consort diagram highlighting the flow of patients through the National Cancer Research Network Pomi-T study.
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fig1: Consort diagram highlighting the flow of patients through the National Cancer Research Network Pomi-T study.

Mentions: Following written informed consent, men were randomised by externally generated, numerically sequenced, opaque, tamper-proof envelopes to the food supplement group (FSG) or placebo group (PG). There was a 2:1 randomisation which resulted in 136 in the FSG and 67 in the PG. Four men withdrew consent after initial randomisation and proceeded to intervention before the 3-month consultation (two from each group), had no further relevant PSA and as such could not be included in an intention to treat analysis (Figure 1). At baseline, 3 months and 6 months post intervention, PSA, full blood count, urea and electrolytes, liver function profile, blood glucose, fasting cholesterol, C-reactive protein, body weight, height and blood pressure were measured. Adverse and favourable events were recorded in the Case Report Form according to the National Cancer Institute (NCI) common toxicity grading scale.


A double-blind, placebo-controlled randomised trial evaluating the effect of a polyphenol-rich whole food supplement on PSA progression in men with prostate cancer--the U.K. NCRN Pomi-T study.

Thomas R, Williams M, Sharma H, Chaudry A, Bellamy P - Prostate Cancer Prostatic Dis. (2014)

Consort diagram highlighting the flow of patients through the National Cancer Research Network Pomi-T study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4020278&req=5

fig1: Consort diagram highlighting the flow of patients through the National Cancer Research Network Pomi-T study.
Mentions: Following written informed consent, men were randomised by externally generated, numerically sequenced, opaque, tamper-proof envelopes to the food supplement group (FSG) or placebo group (PG). There was a 2:1 randomisation which resulted in 136 in the FSG and 67 in the PG. Four men withdrew consent after initial randomisation and proceeded to intervention before the 3-month consultation (two from each group), had no further relevant PSA and as such could not be included in an intention to treat analysis (Figure 1). At baseline, 3 months and 6 months post intervention, PSA, full blood count, urea and electrolytes, liver function profile, blood glucose, fasting cholesterol, C-reactive protein, body weight, height and blood pressure were measured. Adverse and favourable events were recorded in the Case Report Form according to the National Cancer Institute (NCI) common toxicity grading scale.

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: 1] The Primrose Research Unit, Bedford Hospital, Bedford, UK [2] Department of Oncology, Addenbrooke's Cambridge University NHS Trust, Cambridge, UK [3] Department of Postgraduate Medicine, Cranfield University, Cranfield, UK.

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.

Show MeSH
Related in: MedlinePlus