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Rectal Diseases

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Adenomatous Polyps

Adenoma

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Neoplasms by Histologic Type

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Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Herbal and Botanical

All Drugs and Chemicals

Raspberry

20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS

20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS

Black raspberry (BRB) Slurry

Black Raspberry (BRB) Suppositories

Black Raspberry (BRB) Placebo Slurry

Carol A Burke, MD

This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.

Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)

A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries

The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.

A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis.

Ohio State University Comprehensive Cancer Center

The Cleveland Clinic

Principal Investigator

Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.

20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.

Black Raspberry Placebo Slurry Plus 2 Berry Suppositories

20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.

Black Raspberry Slurry Plus 2 Berry Suppositories

20 g of lyophilized berry powder administered orally 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries

Two Berry Suppositories Bedtime Plus Oral Berry Powder

20 g of placebo powder administered as an oral slurry 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries

Two Berry Suppositories Bedtime Plus Placebo Powder

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Carol Burke

All patients received BRB suppositories and were pooled for the analysis comparing baseline and end of study polyp counts.

Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .

Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo

2 lyphilized black raspberry suppositories plus black raspberry slurry.

Lypholized BRB Suppositiry Plus BRB Slurry

All Participants

Change From Baseline to End of Study in Number of Rectal Polyps

KI 67 assay at baseline

KI 67 at 36 weeks

Difference in means of KI 67

Tunel assay at baseline

Tunel assay at 36 weeks

Difference in mean of Tunel

all participants combined for this analysis. Sample of normal mucosa

Normal Mucosa

Polyp

Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.

Two, 730 mg BRB suppositories administered at bedtime.

Lyophilized Black Raspberry (BRB) Suppositories + Placebo

Lyophilized BRB Suppositories + BRB Slurry

Change in Burden of Rectal Polyps

Placebo Powder Plus 2 Berry Suppositories

Overall Study

Spots Global Cancer Trial Database for black raspberry (brb) placebo slurry