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

This study has been completed.
Sponsor:
Collaborator:
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Carol Burke, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00770991
First received: October 9, 2008
Last updated: February 11, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Familial Adenomatous Polyposis
Drug: Black raspberry (BRB) Slurry
Drug: Black Raspberry (BRB) Suppositories
Drug: Black Raspberry (BRB) Placebo Slurry
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change From Baseline to End of Study in Number of Rectal Polyps [ Time Frame: Baseline and 36 weeks ] [ Designated as safety issue: No ]
  • Change in Burden of Rectal Polyps [ Time Frame: Baseline and 36 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline and 36 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Black Raspberry (BRB) Slurry plus BRB suppositories
20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
Drug: Black raspberry (BRB) Slurry
20 grams BRB Slurry
Drug: Black Raspberry (BRB) Suppositories
Two, 730 mg BRB suppositories QHS
Experimental: Black Raspberry (BRB) Placebo Slurry plus BRB suppositories
20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
Drug: Black Raspberry (BRB) Suppositories
Two, 730 mg BRB suppositories QHS
Drug: Black Raspberry (BRB) Placebo Slurry
20 grams BRB placebo slurry

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770991

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Carol A Burke, MD The Cleveland Clinic
  More Information

Responsible Party: Carol Burke, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00770991     History of Changes
Other Study ID Numbers: 2003-34501-13965 
Study First Received: October 9, 2008
Results First Received: February 11, 2016
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Polyp, Familial Adenomatous Polyposis, Prevention

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenoma
Adenomatous Polyps
Colonic Diseases
Colonic Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary

ClinicalTrials.gov processed this record on May 02, 2016