Familial Adenomatous PolyposisPhase 1NCT00770991

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

A Phase 1 study testing Black raspberry (BRB) Slurry and Black Raspberry (BRB) Suppositories in people with Familial Adenomatous Polyposis, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Familial Adenomatous Polyposis
What is being tested?: Black raspberry (BRB) Slurry and Black Raspberry (BRB) Suppositories
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Dec 2005to Dec 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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.

Conditions: Familial Adenomatous Polyposis
Being tested: Black raspberry (BRB) Slurry, Black Raspberry (BRB) Suppositories, Black Raspberry (BRB) Placebo Slurry
Keywords: Polyp, Familial Adenomatous Polyposis, Prevention
Medical subject headings: Adenomatous Polyposis Coli, Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Black raspberry (BRB) SlurryDrug
20 grams BRB Slurry
Black Raspberry (BRB) SuppositoriesDrug
Two, 730 mg BRB suppositories QHS
Black Raspberry (BRB) Placebo SlurryDrug
20 grams BRB placebo slurry

Study groups in NCT00770991
Study group	Role	What they receive
Black Raspberry (BRB) Slurry plus BRB suppositories	Experimental	20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS Receives: Drug: Black raspberry (BRB) Slurry; Drug: Black Raspberry (BRB) Suppositories
Black Raspberry (BRB) Placebo Slurry plus BRB suppositories	Experimental	20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS Receives: Drug: Black Raspberry (BRB) Suppositories; Drug: Black Raspberry (BRB) Placebo Slurry

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to End of Study in Number of Rectal Polyps
Measured: Baseline and 36 weeks
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.
Measured: Baseline and 36 weeks

Secondary outcomes (1)

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.
Measured: baseline and 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Dec 2008

First posted10 Oct 2008 (estimated)
Study startDec 2005
Primary completionSep 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00770991
Sponsor's protocol ID: 2003-34501-13965
Status last verified: Feb 2016
First submitted: 9 Oct 2008
Last updated: 15 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Enrolling by invitation
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
FAP, Familial Adenomatous Polyposis
RecruitingPhase 2
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Colorectal Carcinoma, Familial Adenomatous Polyposis
Not yet recruitingPhase 1
A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).
Familial Adenomatous Polyposis (FAP)

All Familial Adenomatous Polyposis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
ClinicalTrials.gov ID: NCT00770991
Acronym / sponsor ID: 2003-34501-13965
Conditions: Familial Adenomatous Polyposis
Keywords: Polyp, Familial Adenomatous Polyposis, Prevention
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Ohio State University Comprehensive Cancer Center
Study start: Dec 2005
Primary completion: Sep 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 10 Oct 2008 (estimated)
Results: Posted 15 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Black Raspberry (BRB) Slurry plus BRB suppositories	Experimental	Drug: Black raspberry (BRB) Slurry, Drug: Black Raspberry (BRB) Suppositories20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
Black Raspberry (BRB) Placebo Slurry plus BRB suppositories	Experimental	Drug: Black Raspberry (BRB) Suppositories, Drug: Black Raspberry (BRB) Placebo Slurry20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Black raspberry (BRB) Slurry20 grams BRB Slurry	Drug	Black Raspberry (BRB) Slurry plus BRB suppositories
Black Raspberry (BRB) SuppositoriesTwo, 730 mg BRB suppositories QHS	Drug	Black Raspberry (BRB) Placebo Slurry plus BRB suppositories, Black Raspberry (BRB) Slurry plus BRB suppositories
Black Raspberry (BRB) Placebo Slurry20 grams BRB placebo slurry	Drug	Black Raspberry (BRB) Placebo Slurry plus BRB suppositories

Primary outcome

Change From Baseline to End of Study in Number of Rectal Polyps
Time frame: Baseline and 36 weeks
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.

1 secondary outcome

Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
Time frame: baseline and 36 weeks

Results and safety

Results posted to the registry on 15 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Powder Plus 2 Berry Suppositories	12	7
Black Raspberry Slurry Plus 2 Berry Suppositories	12	7

Primary outcome: Change From Baseline to End of Study in Number of Rectal Polyps

Time frame: Baseline and 36 weeks. Mean (Standard Deviation). Unit: polyps

Measure	Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo n = 7	Lypholized BRB Suppositiry Plus BRB Slurry n = 7	All Participants n = 14
Value	-5.4 (5.3)	-1.6 (9.2)	-3.5 (7.5)

All Participants: p = 0.065, Wilcoxon (Mann-Whitney)

Primary outcome: Change in Burden of Rectal Polyps

Time frame: Baseline and 36 weeks. Mean (Standard Deviation). Unit: polyp number x mm

Measure	Lyophilized Black Raspberry (BRB) Suppositories + Placebo n = 7	Lyophilized BRB Suppositories + BRB Slurry n = 7	All Participants n = 14
Value	-13 (11.7)	-5.7 (26.6)	-9.4 (20.1)

All Participants: p = 0.043, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Black Raspberry Placebo Slurry Plus 2 Berry Suppositories	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
Black Raspberry Slurry Plus 2 Berry Suppositories	1 of 12 (8.3%)	10 of 12 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Familial Adenomatous Polyposis

RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Enrolling by invitation
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
FAP, Familial Adenomatous Polyposis
RecruitingPhase 2
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Colorectal Carcinoma, Familial Adenomatous Polyposis
Not yet recruitingPhase 1
A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).
Familial Adenomatous Polyposis (FAP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carol A Burke, MD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Black raspberry (BRB) Slurry and Black Raspberry (BRB) Suppositories in people with Familial Adenomatous Polyposis, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to End of Study in Number of Rectal Polyps (time frame: Baseline and 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00770991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.