Evidence map›Paper›PMID 27658890›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2016

A Randomized Phase IIb Trial of myo-Inositol in Smokers with Bronchial Dysplasia.

Stephen Lam, Sumithra J Mandrekar, Yaron Gesthalter, Katie L Allen Ziegler, Drew K Seisler, David E Midthun, Jenny T Mao, Marie Christine Aubry, Annette McWilliams, Don D Sin and 16 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.4field-weighted citation impact, top 5% 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

23 citing papers in PubMed, 36 citations in OpenAlex.

  1. Trial
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  18. Airway Microbiota Is Associated with Upregulation of the PI3K Pathway in Lung Cancer.American journal of respiratory and critical care medicine · 2018
    Article
  19. AJournal of thoracic disease · 2018
    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

26 authors at 2 institutions in 2 countries.

Stephen LamBritish Columbia Cancer Agency, Vancouver, British Columbia, Canada. slam2@bccancer.bc.ca.
Sumithra J MandrekarMayo Clinic, Rochester, Minnesota.
Yaron GesthalterBoston University Medical Center, Boston, Massachusetts.
Katie L Allen ZieglerMayo Clinic, Rochester, Minnesota.
Drew K SeislerMayo Clinic, Rochester, Minnesota.
David E MidthunMayo Clinic, Rochester, Minnesota.
Jenny T MaoNew Mexico Veteran's Health Care System, Albuquerque, New Mexico.
Marie Christine AubryMayo Clinic, Rochester, Minnesota.
Annette McWilliamsFiona Stanley Hospital, Palmyra DC, Western Australia.
Don D SinSt. Paul's Hospital, Vancouver, British Columbia, Canada.
Tawimas ShaipanichBritish Columbia Cancer Agency, Vancouver, British Columbia, Canada.
Gang LiuBoston University Medical Center, Boston, Massachusetts.
Evan JohnsonBoston University Medical Center, Boston, Massachusetts.
Andrea BildUniversity of Utah, Salt Lake City, Utah.
Marc E LenburgBoston University Medical Center, Boston, Massachusetts.
Diana N IonescuBritish Columbia Cancer Agency, Vancouver, British Columbia, Canada.
John MayoVancouver General Hospital, Vancouver, British Columbia.
Joanne Eunhee YiMayo Clinic, Rochester, Minnesota.
Henry TazelaarMayo Clinic, Scottsdale, Arizona.
William S HarmsenMayo Clinic, Rochester, Minnesota.
Judith SmithDivision of Cancer Prevention, National Cancer Institute, NIH, Bethesda, Maryland.
Avrum E SpiraBoston University Medical Center, Boston, Massachusetts.
Jennifer BeaneBoston University Medical Center, Boston, Massachusetts.
Paul J LimburgMayo Clinic, Rochester, Minnesota.
Eva SzaboDivision of Cancer Prevention, National Cancer Institute, NIH, Bethesda, Maryland.
Cancer Prevention Network
Mayo Clinic · USBC Cancer Agency · CA

Funding

PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS -261035000N01CN035000 · CN · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LIMBURG, PAUL J · 1985 to 2006
–
NCI NIH HHS N01 CN035000
6 · The paper itself

Abstract

Previous preclinical studies and a phase I clinical trial suggested that myo-inositol may be a safe and effective lung cancer chemopreventive agent. We conducted a randomized, double blind, placebo-controlled phase IIb study to determine the chemopreventive effects of myo-inositol in smokers with bronchial dysplasia. Smokers with ≥1 site of dysplasia identified by autofluorescence bronchoscopy-directed biopsy were randomly assigned to receive oral placebo or myo-inositol, 9 g once a day for 2 weeks, and then twice a day for 6 months. The primary endpoint was change in dysplasia rate after 6 months of intervention on a per-participant basis. Other trial endpoints reported herein include Ki-67 labeling index, blood and bronchoalveolar lavage fluid (BAL) levels of proinflammatory, oxidant/antioxidant biomarkers, and an airway epithelial gene expression signature for PI3K activity. Seventy-four (n = 38 myo-inositol and n = 36 placebo) participants with a baseline and 6-month bronchoscopy were included in all efficacy analyses. The complete response and the progressive disease rates were 26.3% versus 13.9% and 47.4% versus 33.3%, respectively, in the myo-inositol and placebo arms (P = 0.76). Compared with placebo, myo-inositol intervention significantly reduced IL6 levels in BAL over 6 months (P = 0.03). Among those with a complete response in the myo-inositol arm, there was a significant decrease in a gene expression signature reflective of PI3K activation within the cytologically normal bronchial airway epithelium (P = 0.002). The heterogeneous response to myo-inositol suggests a targeted therapy approach based on molecular alterations is needed in future clinical trials to determine the efficacy of myo-inositol as a chemopreventive agent. Cancer Prev Res; 9(12); 906-14. ©2016 AACR.

Indexed as

AgedBiomarkers, TumorBiopsyBronchiBronchoalveolar Lavage FluidBronchoscopyChemopreventionDose-Response Relationship, DrugDouble-Blind MethodFemaleGlucoseHumansHyperplasiaInositolKi-67 AntigenLung NeoplasmsBiomarkers, TumorGlucoseInositolKi-67 AntigenPhosphatidylinositol 3-KinasesVitamin B Complex

Identifiers

PMID27658890
PMCPMC5136333
OpenAlexW2522736967

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.