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| Name | Class |
|---|---|
| Ohio State University Comprehensive Cancer Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black Raspberry (BRB) Slurry plus BRB suppositories | Experimental | 20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS |
|
| Black Raspberry (BRB) Placebo Slurry plus BRB suppositories | Experimental | 20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black raspberry (BRB) Slurry | Drug | 20 grams BRB Slurry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Study in Number of Rectal Polyps | Baseline and 36 weeks | |
| Change in Burden of Rectal Polyps | 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. | Baseline and 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Apoptosis and Cell Proliferation Measured by Percent Difference in Staining. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol A Burke, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
After potentially eligible subjects signed the informed consent, a physical examination with medical history and colonoscopy or sigmoidoscopy was performed as indicated. Blood and urine samples were collected. Subjects with adequate rectal polyp burden and laboratory results within study guidelines were eligible to be randomized.
Study was open for enrollment at Cleveland Clinic from December 9, 2005 to March 26, 2008. Subjects with FAP who had an assessable rectal segment were screened for potential eligibility. Once it was determined the subjects were potentially eligible they were contacted by phone or letter.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Powder Plus 2 Berry Suppositories | 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. |
| FG001 | Black Raspberry 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Two Berry Suppositories Bedtime Plus Oral Berry Powder | 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 |
| BG001 | Two Berry Suppositories Bedtime Plus Placebo Powder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to End of Study in Number of Rectal Polyps | Posted | Mean | Standard Deviation | polyps | Baseline and 36 weeks |
|
Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Black Raspberry Placebo Slurry Plus 2 Berry Suppositories | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small Bowel Obstruction | Gastrointestinal disorders | other | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal bloating | Gastrointestinal disorders | other | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carol Burke | Cleveland Clinic | 216 444-6864 | burkec1@ccf.org |
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| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013488 | Suppositories |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Black Raspberry (BRB) Suppositories | Drug | Two, 730 mg BRB suppositories QHS |
|
| Black Raspberry (BRB) Placebo Slurry | Drug | 20 grams BRB placebo slurry |
|
| baseline and 36 weeks |
| Adverse Event |
|
| Pregnancy |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Apoptosis and Cell Proliferation Measured by Percent Difference in Staining. | 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. | Posted | Mean | Standard Deviation | percentage of brown staining of cells | baseline and 36 weeks |
|
|
|
|
| Primary | Change in Burden of Rectal Polyps | 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. | Posted | Mean | Standard Deviation | polyp number x mm | Baseline and 36 weeks |
|
|
|
|
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | Black Raspberry 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. | 1 | 12 | 10 | 12 |
| Anal fissure | Gastrointestinal disorders | other | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | other | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | other | Systematic Assessment |
|
| Fatigue | General disorders | other | Systematic Assessment |
|
| Increased appetite | General disorders | other | Systematic Assessment |
|
| Flatulance | Gastrointestinal disorders | other | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | other | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | other | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | other | Systematic Assessment |
|
| Elevated ALT and AST | Hepatobiliary disorders | other | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | other | Systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | other | Systematic Assessment |
|
| Cramping in extremities | Nervous system disorders | other | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Difference in means of KI 67 |
|
| Tunel assay at baseline |
|
| Tunel assay at 36 weeks |
|
| Difference in mean of Tunel |
|