Evidence map›Paper›PMID 24614693›Full record

Trial reportProstate cancer and prostatic diseases2014

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.

R Thomas, M Williams, H Sharma, A Chaudry, P Bellamy

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Prostate cancer and prostatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04208334 (A Double-blind, Placebo-controlled Randomized Trial Phase II Evaluating the Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer), which is not on this map. Cited by 59 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 5 pooled it
9.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04208334 phase2completednot on this mapstarted 2020, after this paper: background citation

A Double-blind, Placebo-controlled Randomized Trial Phase II Evaluating the Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer

TypeinterventionalSponsorPhramongkutklao College of Medicine and HospitalRan2020 to 2021Enrolled20ConditionsCancer Cachexia, Head and Neck Cancer, Head and Neck NeoplasmsArmsCurcumin, Placebo
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 5 syntheses or guidelines pooled it, 139 citations in OpenAlex.

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  7. Effect of green tea and lycopene on the insulin-like growth factor system: the ProDiet randomized controlled trial.European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP) · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

R Thomas1] 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.
M WilliamsThe Primrose Research Unit, Bedford Hospital, Bedford, UK.
H SharmaThe Primrose Research Unit, Bedford Hospital, Bedford, UK.
A ChaudryDepartment of Oncology, Addenbrooke's Cambridge University NHS Trust, Cambridge, UK.
P BellamyDepartment of Postgraduate Medicine, Cranfield University, Cranfield, UK.
Bedford Hospital · GBCambridge University Hospitals NHS Foundation Trust · GBCranfield University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolyphenol-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.

methodsIn 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.

resultsThe 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.

conclusionsThis 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.

Indexed as

AgedAged, 80 and overBrassicaCurcumaDietary SupplementsDisease ProgressionDouble-Blind MethodHumansKallikreinsLythraceaeMaleMiddle AgedPolyphenolsProstate-Specific AntigenProstatic NeoplasmsTeaKallikreinsKLK3 protein, humanPolyphenolsProstate-Specific AntigenTea

Identifiers

PMID24614693
PMCPMC4020278
OpenAlexW2167854858

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.