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:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00770991
First received: October 9, 2008
Last updated: April 7, 2011
Last verified: April 2011
  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 initation 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: Lyophilized Black Raspberries
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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:
  • To determine whether daily exposure of Black Raspberries reduces the number of rectal polyps in subjects with FAP. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biomarker indices from biopsies of normal rectal mucosa, polyps and aberrant crypt foci will be evaluated at baseline and 36 weeks to determine if black raspberries modulate their activity. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 14
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
Placebo Comparator: Sugar Pill
Sugar Pill
Drug: Placebo
Sugar Pill
Active Comparator: Lyophilized Black Raspberries Drug: Lyophilized Black Raspberries
Lyophilized Black Raspberries

  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 Clnic
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

No publications provided

Responsible Party: Carol A. Burke, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00770991     History of Changes
Other Study ID Numbers: 2003-34501-13965
Study First Received: October 9, 2008
Last Updated: April 7, 2011
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
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014