Evidence map›Paper›PMID 28102098›Full record

Trial reportIntegrative cancer therapies2018

A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer.

Mridul Datta, Edward G Shaw, Glenn J Lesser, L Douglas Case, Mara Z Vitolins, Charles Schneider, Bart Frizzell, Christopher Sullivan, Mark Lively, Elizabeth Franzmann and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Integrative cancer therapies, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 100% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
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

11 authors at 3 institutions in 1 country.

Mridul Datta1 Purdue University, West Lafayette, IN, USA.
Edward G Shaw2 Wake Forest Comprehensive Cancer Center, Winston-Salem, NC, USA.
Glenn J Lesser3 Wake Forest School of Medicine, Winston-Salem, NC, USA.
L Douglas Case3 Wake Forest School of Medicine, Winston-Salem, NC, USA.
Mara Z Vitolins3 Wake Forest School of Medicine, Winston-Salem, NC, USA.
Charles Schneider4 Helen F. Graham Cancer Center, Newark, DE, USA.
Bart Frizzell3 Wake Forest School of Medicine, Winston-Salem, NC, USA.
Christopher Sullivan3 Wake Forest School of Medicine, Winston-Salem, NC, USA.
Mark Lively3 Wake Forest School of Medicine, Winston-Salem, NC, USA.
Elizabeth Franzmann5 University of Miami School of Medicine, Miami, FL, USA.
Jennifer J Hu5 University of Miami School of Medicine, Miami, FL, USA.
Wake Forest University · USUniversity of Miami · USPurdue University West Lafayette · US

Funding

Wake Forest NCORP Research BaseUG1CA189824 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Emily Van Meter Dressler, GLENN J LESSER · 2014 to 2026
$57.9M
Comprehensive Cancer Center of Wake Forest University CCOP Research BaseU10CA081851 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI SHAW, EDWARD G · 1999 to 2013
$22.0M
Postdoctoral Training Program in Cancer SurvivorshipR25CA122061 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI AVIS, NANCY E · 2008 to 2018
$3.8M
EFFECTS OF FRUIT &VEGETABLE EXTRACTS ON CANCER MARKERSR21CA106205 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI AKMAN, STEVEN A · 2003 to 2004
$431k
NCI NIH HHS R21 CA106205NCI NIH HHS R25 CA122061NCI NIH HHS U10 CA081851NCI NIH HHS UG1 CA189824
6 · The paper itself

Abstract

backgroundHead and neck cancer (HNC) patients are at an increased risk for developing second primary tumors (SPTs). Diets rich in fruits and vegetables (FVs) may lower HNC risk. FV concentrates may offer a potential alternative to increasing FV intake.

methodsWe conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has an effect on p27 and Ki-67, biomarkers associated with the risk of SPTs. During 2004-2008, we randomized 134 HNC patients to 12 weeks of JP (n = 72) or placebo (n = 62). Oral cavity mucosal biopsies and whole blood were obtained at baseline and after 12 weeks. All participants were given the opportunity to receive JP for 5 years following the end of the intervention period, and they were followed yearly for the development of SPTs.

resultsAfter 12 weeks, patients on JP had significantly higher serum α-carotene ( P = .009), β-carotene ( P < .0001), and lutein ( P = .003) but did not differ significantly in p27 ( P = .23) or Ki-67 ( P = .95). JP use following the initial 12-week trial was not significantly associated with SPT prevention.

conclusionsDespite increased serum micronutrient levels, our results do not suggest a clinical benefit of JP in HNC patients. Future studies should focus on longer intervention periods and/or modified supplement formulations with demonstrated chemopreventive properties.

Indexed as

Fruit and Vegetable JuicesAntioxidantsBiomarkers, TumorDietary SupplementsDouble-Blind MethodHead and Neck NeoplasmsHumansKi-67 AntigenMicronutrientsPhytotherapyPlant ExtractsPowdersProliferating Cell Nuclear AntigenAntioxidantsBiomarkers, TumorKi-67 AntigenMicronutrientsp27 antigenPlant ExtractsPowdersProliferating Cell Nuclear Antigenfruit/vegetable concentratehead and neck cancerKi-67p27surrogate end point biomarkers

Identifiers

PMID28102098
PMCPMC5501769
OpenAlexW2577957758

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.