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

NCT03061591 | Unknown Phase 2

• 1 other identifier: TASMC-15-RK-0601-CTIL
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Familial Adenomatous Polyposis; FAP; FAP Gene Mutation

Keywords

Turmeric; Curcumin; colorectal polyps; colorectal neoplasia; mutyh mutation; apc mutation

Outcome Measures

Primary Outcomes (2)

• Number of polyps

  6 months

• Size of polyps

  6 months

Secondary Outcomes (7)

• Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).

  6 months

• Histological proliferation assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).

  6 months

• Colonic microbiome composition, after curcumin therapy.

  6 months

• Duodenal adenoma number.

  6 months

• Duodenal adenoma size.

  6 months

Study Arms (2)

Wholistic Turmeric capsules

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Identical placebo capsules

Other: Placebo

Interventions

Wholistic Turmeric capsules DIETARY_SUPPLEMENT

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.

Wholistic Turmeric capsules

Placebo OTHER

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (3)

• 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. doi: 10.1016/j.cgh.2006.03.020. Epub 2006 Jun 6.

  PMID: 16757216 BACKGROUND

• 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.

  PMID: 12050094 BACKGROUND

• 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.

  PMID: 22953026 BACKGROUND

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Revital Kariv, MD

  Tel Aviv SMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Fliss, MSc

CONTACT

97236974458; naomifl@tlvmc.gov.il

Sivan Kaspi, RD

CONTACT

97236974458; sivanah@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Development department

Model Details: 6 months of Curcumin vs. placebo treatment outcomes will be compared.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: April 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2020
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share