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

Primary Purpose

Familial Adenomatous Polyposis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Black raspberry (BRB) Slurry
Black Raspberry (BRB) Suppositories
Black Raspberry (BRB) Placebo Slurry
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Familial Adenomatous Polyposis focused on measuring Polyp, Familial Adenomatous Polyposis, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy
  • Have an endoscopically assessable rectal segment
  • Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration.

Exclusion Criteria:

  • Known allergies or hypersensitivity to berries
  • Diabetes mellitus
  • Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Black Raspberry (BRB) Slurry plus BRB suppositories

Black Raspberry (BRB) Placebo Slurry plus BRB suppositories

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 9, 2008
Last Updated
February 11, 2016
Sponsor
The Cleveland Clinic
Collaborators
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00770991
Brief Title
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Official Title
A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Adenomatous Polyposis
Keywords
Polyp, Familial Adenomatous Polyposis, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Black Raspberry (BRB) Slurry plus BRB suppositories
Arm Type
Experimental
Arm Description
20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
Arm Title
Black Raspberry (BRB) Placebo Slurry plus BRB suppositories
Arm Type
Experimental
Arm Description
20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
Intervention Type
Drug
Intervention Name(s)
Black raspberry (BRB) Slurry
Intervention Description
20 grams BRB Slurry
Intervention Type
Drug
Intervention Name(s)
Black Raspberry (BRB) Suppositories
Intervention Description
Two, 730 mg BRB suppositories QHS
Intervention Type
Drug
Intervention Name(s)
Black Raspberry (BRB) Placebo Slurry
Intervention Description
20 grams BRB placebo slurry
Primary Outcome Measure Information:
Title
Change From Baseline to End of Study in Number of Rectal Polyps
Time Frame
Baseline and 36 weeks
Title
Change in Burden of Rectal Polyps
Description
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.
Time Frame
Baseline and 36 weeks
Secondary Outcome Measure Information:
Title
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
Description
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.
Time Frame
baseline and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy Have an endoscopically assessable rectal segment Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration. Exclusion Criteria: Known allergies or hypersensitivity to berries Diabetes mellitus Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Burke, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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