Table 2

Pilot clinical trials of BRBs in at-risk populations

TrialDelivery routeNo. patientsBiomarkersStatusReferences
Barrett's esophagusOral20Lesion sizeComplete(43)
Histopathology
Cell proliferation
Oxidative stress
Phase II enzymes
Esophageal dysplasiaOral60Lesion sizeOngoing
Histopathology
Cell proliferation
COX-2, iNOS
Oral dysplasiaBerry gel27Lesion sizeComplete(44, 45)
Histopathology
Loss of heterozygosity
COX-2, iNOS
Gene modulation (microarray)
Colon cancerOral30Cell proliferationComplete(48)
Apoptosis
Angiogenesis
β-Catenin
E-cadherin
c-myc
Cyclin D1
Rectal polypsOral and rectal suppository14Polyp numberComplete(49)
Polyp size
Prostate cancerOral20Cell proliferationOngoing
Prostate-specific antigen
Oral cancerLozenge35NF-κB and other genesOngoing(46, 47)

Abbreviations: COX-2, cyclooxygenase-2; iNOS, inducible nitric oxide synthase; NF-κB, nuclear factor κB.