Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis.

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ClinicalTrials.gov Identifier: NCT03061591

Recruitment Status : Unknown

Verified February 2017 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting

First Posted : February 23, 2017

Last Update Posted : February 23, 2017

Sponsor:

Information provided by (Responsible Party):

michal roll, Tel-Aviv Sourasky Medical Center

Study Description

Brief Summary:

A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve treatment with 8 capsuls (2*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or placebo for six months.

Condition or disease	Intervention/treatment	Phase
Familial Adenomatous Polyposis FAP FAP Gene Mutation	Dietary Supplement: Wholistic Turmeric capsules Other: Placebo	Phase 2

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Detailed Description:

Fourty individuals with identified APC mutation or MUTYH mutation that result in a phenotype of multiple colonic adenomas with or without duodenal adenomas will be included in the study. Participants will be allocated in a 1:1 ratio to receive either wholistic Turmeric capsules (Pukka herbs) or placebo for 6 months.

Participants will be assessed by a gastroenterologist 4-8 weeks after initiation, and at termination/conclusion visit at 6 months.

Blood, stool and urine samples will be collected at baseline, after 4-8 weeks and at 6 months just before final colonoscopy.

Serum samples will be used for testing complete blood count, liver function test, C-reactive protein (CRP) Various cytokines and small molecule measurements. Stool samples will be evaluated for microbiome composition.

Curcumin and curcuminoid levels will be measured in tissue serum, stool and urine will be measured in a subsample of patients.

Colonoscopy will be performed at study entry with removal of all polyps larger than 20mm, count and precise size measurement of polyps by a standard forceps, throughout the colon and in defined segments. Retained polyps will be counted and measured with an open forceps placed near the polyp to determine size. A full video and photos of the procedure will be taken. In cases with multiple polyps that cannot be counted or properly evaluated the PI will decide if a defined area like the rectum could be evaluated and will define it in terms of distance from the anus. In this case the video of the procedure will be evaluated by two separate gastroeneterologists blinded to treatment arm.

Frozen samples from normal mucosa will be taken at study entry. Samples from polyps will be taken preferably in cases with multiple polyp in order not to interrupt measurments.

Upper endoscopy only in patients with known duodenal adenomas will also be performed at study entry with as above evaluation. Sample from polyps and normal mucosa will be taken as above. A full video and photos of the upper endoscopy will be recorded as well.

A 2nd colonoscopy +/- gastroscopy will be performed at 6 months when all polyps will be counted and pictured by video and photography. Size determination in a similar way as above, throughout the colon or in the defined area as was decided at baseline colonoscopy.

Frozen samples from polyps and normal mucosa will be taken and polypoectomy will be performed upon the decision of the endoscopist in both lower and upper endoscopies.

Frozen tissue specimen will be used for H&E, various proliferation and apoptosis staining like KI67.

Tissue, blood, urine and stool samples will be frozen and sent for analysis.

Inclusion/screening visit will include:

Intake of patient medical history.
Exact documentation of identified genetic mutation per genetic consultation
Case report form (CRF).
Blood test including complete blood count, liver function test, C-reactive protein (CRP) and sera for subsequent cytokine analysis.
Urine and Stool collection .
Basline colonoscopy and/or upper endoscopy as detiled above with tissue collection and tattoo of tissue sampled.

Mid-term visit at 4-8 weeks will include:

Case report form (CRF).
Collection of Blood, urine and stool specimens.

Termination/conclusion visit will include:

Case report form (CRF).
Collection of blood, urine, stool specimens
Colonoscopy and upper endoscopy as described above with tissue collection of same tissue identified by tattoo.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	6 months of Curcumin vs. placebo treatment outcomes will be compared.
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:	Placebo and curcumin capsules are identical in appearance, and will be marked as "A" or "B". Study participants and staff will be blinded to the capsule content. A locked file containing the description will remain in a locked file on the study coordinators computer.
Primary Purpose:	Treatment
Official Title:	Efficacy of Wholistic Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis A Randomized, Double Blinded, Placebo Controlled Study
Estimated Study Start Date :	April 2017
Estimated Primary Completion Date :	April 2018
Estimated Study Completion Date :	April 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial adenomatous polyposis

MedlinePlus related topics: Family Issues

Drug Information available for: Curcuma longa extract Curcuma domestica

Genetic and Rare Diseases Information Center resources: Familial Adenomatous Polyposis MYH-associated Polyposis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Wholistic Turmeric capsules Oral capsules of wholistic Turmeric capsules (Pukka herbs) (each capsule 100 mg curcumin) divided twice daily, or an identical placebo in 2 divided doses daily all taken before meals. Pukka's Wholistic Turmeric	Dietary Supplement: Wholistic Turmeric capsules Oral capsules of wholistic Turmeric capsules (Pukka herbs) curcumin (each capsule 0.5100 m gr curcumin) for a total of 4 gr/d divided twice daily.
Placebo Comparator: Placebo Identical placebo capsules	Other: Placebo Placebo capsules

Outcome Measures

Primary Outcome Measures :

Number of polyps [ Time Frame: 6 months ]
Size of polyps [ Time Frame: 6 months ]

Secondary Outcome Measures :

Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression). [ Time Frame: 6 months ]
Histological proliferation assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression). [ Time Frame: 6 months ]
Colonic microbiome composition, after curcumin therapy. [ Time Frame: 6 months ]
Duodenal adenoma number. [ Time Frame: 6 months ]
Duodenal adenoma size. [ Time Frame: 6 months ]
Curcumin and curcuminoid levels in blood. [ Time Frame: 6 months ]
Curcumin and curcuminoid levels in urine. [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

An established clinical diagnosis of Familial Polyposis based on accepted clinical/ endoscopic and an identified APC or MUTYH mutation
Age 18-70 years.
Willing and able to give written consent.
At least 5 polyps, 2mm or lrager, with at least one larger then 4mm but not more then 20mm.
Colonic polyp burden that can be estimated by either counting or photographing(photo or video).

Exclusion criteria:

Pregnant or nursing women.
Stable does of any COX inhibitor drugs for more than 3 months prior to study entry,.
Concomitant severe or uncontrolled cardiovascular, hepatic, renal or metabolic disease.
Known allergy to curcumin.
Anticipated surgery within 6 months
Diagnosed polyps of high grade dysplasia or of adenocarcinomas in the GI on screening colonoscopy.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061591

Contacts

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Contact: Naomi Fliss, MSc	97236974458	naomifl@tlvmc.gov.il
Contact: Sivan Kaspi, RD	97236974458	sivanah@tlvmc.gov.il

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

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Principal Investigator:	Revital Kariv, MD	Tel Aviv SMC

More Information

Publications:

Cruz-Correa M, Shoskes DA, Sanchez P, Zhao R, Hylind LM, Wexner SD, Giardiello FM. Combination treatment with curcumin and quercetin of adenomas in familial adenomatous polyposis. Clin Gastroenterol Hepatol. 2006 Aug;4(8):1035-8. Epub 2006 Jun 6.

Perkins S, Verschoyle RD, Hill K, Parveen I, Threadgill MD, Sharma RA, Williams ML, Steward WP, Gescher AJ. Chemopreventive efficacy and pharmacokinetics of curcumin in the min/+ mouse, a model of familial adenomatous polyposis. Cancer Epidemiol Biomarkers Prev. 2002 Jun;11(6):535-40.

Pettan-Brewer C, Morton J, Mangalindan R, Ladiges W. Curcumin suppresses intestinal polyps in APC Min mice fed a high fat diet. Pathobiol Aging Age Relat Dis. 2011;1. doi: 10.3402/pba.v1i0.7013. Epub 2011 Jun 1.

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Responsible Party:	michal roll, Head of Research and Development department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT03061591
Other Study ID Numbers:	TASMC-15-RK-0601-CTIL
First Posted:	February 23, 2017 Key Record Dates
Last Update Posted:	February 23, 2017
Last Verified:	February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:


Turmeric Curcumin colorectal polyps	colorectal neoplasia mutyh mutation apc mutation

Additional relevant MeSH terms:

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Colorectal Neoplasms Nasopharyngeal Neoplasms Adenomatous Polyposis Coli Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pharyngeal Neoplasms	Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Adenomatous Polyps Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplastic Syndromes, Hereditary Intestinal Polyposis Genetic Diseases, Inborn

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