Evidence map›Paper›PMID 24486592›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2014

Topical application of a mucoadhesive freeze-dried black raspberry gel induces clinical and histologic regression and reduces loss of heterozygosity events in premalignant oral intraepithelial lesions: results from a multicentered, placebo-controlled clinical trial.

Susan R Mallery, Meng Tong, Brian S Shumway, Alice E Curran, Peter E Larsen, Gregory M Ness, Kelly S Kennedy, George H Blakey, George M Kushner, Aaron M Vickers and 3 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01192204 (Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT01192204 phase1 / phase2completednot on this map

Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

TypeinterventionalSponsorOhio State UniversityRan2010 to 2014Enrolled41ConditionsSquamous Cell Carcinoma of Mouth, Intraepithelial NeoplasiaArms10% FBR containing bioadhesive gel, placebo gel
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Raspberry protective role in inflammatory diseases: An overview.Iranian journal of basic medical sciences · 2026
    Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Green Cancer Prevention and Beyond.Cancer prevention research (Philadelphia, Pa.) · 2024
    Review
  13. Review
  14. Berries vs. Disease: Revenge of the Phytochemicals.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. 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

13 authors at 4 institutions in 1 country.

Susan R MalleryAuthors' Affiliations: Divisions of Oral Maxillofacial Pathology & Radiology and Oral Maxillofacial Surgery & Anesthesiology, College of Dentistry, The Ohio State University; The Ohio State University Comprehensive Cancer, Columbus, Ohio; Departments of Oral & Maxillofacial Pathology and Oral & Maxillofacial Surgery, School of Dentistry, University of Louisville, Kentucky; Departments of Diagnostic Sciences and Oral and Maxillofacial Surgery, University of North Carolina at Chapel Hill School of Dentistry, Chapel Hill, North Carolina; and Division of Hematology and Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.
Meng Tong
Brian S Shumway
Alice E Curran
Peter E Larsen
Gregory M Ness
Kelly S Kennedy
George H Blakey
George M Kushner
Aaron M Vickers
Brian Han
Ping Pei
Gary D Stoner
The Ohio State University · USUniversity of North Carolina at Chapel Hill · USMedical College of Wisconsin · USUniversity of Louisville · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
University of Iowa Clinical and Translational Science Program (TL1)UL1RR025755 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$26.3M
The Ohio State University Center for clinical and Translational ScienceUL1TR001070 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2013 to 2017
$22.6M
Evaluation of locally-delivered fenretinide and black raspberries for oral cancerR01CA171329 · NCI · OHIO STATE UNIVERSITY · PI MALLERY, SUSAN R · 2012 to 2016
$1.6M
Clinical evaluation of a bioadhesive gel for oral cancer chemoprevention.RC2CA148099 · NCI · OHIO STATE UNIVERSITY · PI MALLERY, SUSAN R · 2009 to 2010
$1.3M
NCATS NIH HHS UL1 TR001070NCI NIH HHS NCI RC2 CA148099NCI NIH HHS P30 CA016058NCI NIH HHS R01 CA171329NCI NIH HHS RC2 CA148099NCRR NIH HHS UL1 RR025755
6 · The paper itself

Abstract

purposeApproximately 30% higher grade premalignant oral intraepithelial neoplasia (OIN) lesions will progress to oral cancer. Although surgery is the OIN treatment mainstay, many OIN lesions recur, which is highly problematic for both surgeons and patients. This clinical trial assessed the chemopreventive efficacy of a natural product-based bioadhesive gel on OIN lesions. EXPERIMENTAL

designThis placebo-controlled multicenter study investigated the effects of topical application of bioadhesive gels that contained either 10% w/w freeze-dried black raspberries (BRB) or an identical formulation devoid of BRB placebo to biopsy-confirmed OIN lesions (0.5 g × q.i.d., 12 weeks). Baseline evaluative parameters (size, histologic grade, LOH events) were comparable in the randomly assigned BRB (n = 22) and placebo (n = 18) gel cohorts. Evaluative parameters were: histologic grade, clinical size, and LOH.

resultsTopical application of the BRB gel to OIN lesions resulted in statistically significant reductions in lesional sizes, histologic grades, and LOH events. In contrast, placebo gel lesions demonstrated a significant increase in lesional size and no significant effects on histologic grade or LOH events. Collectively, these data strongly support BRB's chemopreventive impact. A cohort of very BRB-responsive patients, as demonstrated by high therapeutic efficacy, was identified. Corresponding protein profiling studies, which demonstrated higher pretreatment levels of BRB metabolic and keratinocyte differentiation enzymes in BRB-responsive lesions, reinforce the importance of local metabolism and differentiation competency.

conclusionsResults from this trial substantiate the LOH reductions identified in the pilot BRB gel study and extend therapeutic effects to significant improvements in histologic grade and lesional size.

Indexed as

GelsPhytotherapyAdministration, TopicalAdultAgedFemaleFruitHumansMaleMiddle AgedMouth NeoplasmsGels

Identifiers

PMID24486592
PMCPMC3975696
OpenAlexW2123404918

What OpenQuestion holds

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LicenceTDM
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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.