Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Familial Adenomatous Polyposis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

To determine whether daily exposure of Black Raspberries reduces the number of rectal polyps in subjects with FAP.

Outcome Time Frame:

36 weeks

Safety Issue:

Yes

Principal Investigator

Carol A Burke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

2003-34501-13965

NCT ID:

NCT00770991

Start Date:

December 2005

Completion Date:

December 2008

Related Keywords:

  • Familial Adenomatous Polyposis
  • Polyp, Familial Adenomatous Polyposis, Prevention
  • Adenomatous Polyposis Coli
  • Colorectal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

Cleveland ClnicCleveland, Ohio  44195