Table 1.
Clinical trials of BRB targeting premalignancy or cancer
| Population, no. patients | Route & mode of delivery | Dose | Duration of Study | Endpoints | References |
|---|---|---|---|---|---|
| Oral dysplasia (n = 27 and 30) | Direct local delivery in berry gel formulation (n = 17 and 20 w/Premalignancy & n = 10 Controls) | 0.5 g BRB or 10% w/w 4× daily |
6 weeks | Lesion size Histopathology Loss of heterozygosity COX-2, iNOS, CD34 Gene expression |
(17, 18) |
| Oral dysplasia (n = 30) | Direct local delivery in berry gel formulation (n = 22) or placebo (n = 18) | 0.5 g BRB or 10% w/w 4× daily or placebo |
3 months | Lesion size Histopathology Loss of heterozygosity COX-2, iNOS Gene expression |
(19) |
| Barrett’s esophagus (n = 20) | Oral consumption as Lyophilized black raspberries in water suspension | 32 to 45 g BRB 1× daily |
6 months | Cell proliferation Oxidative damage Lipid peroxidation Cholesterol GST-pi, CDX2, NF-κB Ellagitannin metabolites |
(20, 21) |
| Colon Cancer (n = 20) | Oral consumption as Lyophilized black raspberries in water suspension | 20 g BRB 3× daily (oral) |
1–9 weeks | DNA methylation Cell proliferation Apoptosis Angiogenesis β-Catenin,E-Cadherin, c-Myc Cyclin D1 Metabolites |
(22, 23, 24) |
| Familial adenomatous polyposis (n = 14) | Local delivery as rectal suppository alone (n = 7) or in combination w/oral consumption of Lyophilized black raspberries in water suspension (n = 7) | 1.4 g/d BRB suppository alone or in combination w/20 g BRB 3× daily (oral) |
9 months | Polyp number, burden & size DNA methylation APC SNPs Cell proliferation |
(25) |
BRB, abbreviation for black raspberry.