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NCT Number: NCT00770991

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

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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Key information

Conditions

Familial Adenomatous Polyposis Adenoma Adenomatous Polyposis Coli Adenomatous Polyps Colonic Diseases Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities 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 Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Black raspberry (BRB) Slurry

Drug

20 grams BRB Slurry

Black Raspberry (BRB) Suppositories

Drug

Two, 730 mg BRB suppositories QHS

Black Raspberry (BRB) Placebo Slurry

Drug

20 grams BRB placebo slurry

Primary outcomes

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

    Time frame: Baseline and 36 weeks

  2. Change in Burden of Rectal Polyps

    Time frame: Baseline and 36 weeks

    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 outcomes

  1. Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.

    Time frame: baseline and 36 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Ohio State University Comprehensive Cancer Center

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 10, 2008
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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