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

Primary Purpose

Familial Adenomatous Polyposis, FAP, FAP Gene Mutation

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Wholistic Turmeric capsules
Placebo
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial Adenomatous Polyposis focused on measuring Turmeric, Curcumin, colorectal polyps, colorectal neoplasia, mutyh mutation, apc mutation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Wholistic Turmeric capsules

    Placebo

    Arm Description

    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

    Identical placebo capsules

    Outcomes

    Primary Outcome Measures

    Number of polyps
    Size of polyps

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 14, 2017
    Last Updated
    February 19, 2017
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03061591
    Brief Title
    Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis.
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2017 (Anticipated)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    April 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Familial Adenomatous Polyposis, FAP, FAP Gene Mutation
    Keywords
    Turmeric, Curcumin, colorectal polyps, colorectal neoplasia, mutyh mutation, apc mutation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    6 months of Curcumin vs. placebo treatment outcomes will be compared.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Wholistic Turmeric capsules
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Identical placebo capsules
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Wholistic Turmeric capsules
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo capsules
    Primary Outcome Measure Information:
    Title
    Number of polyps
    Time Frame
    6 months
    Title
    Size of polyps
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).
    Time Frame
    6 months
    Title
    Histological proliferation assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).
    Time Frame
    6 months
    Title
    Colonic microbiome composition, after curcumin therapy.
    Time Frame
    6 months
    Title
    Duodenal adenoma number.
    Time Frame
    6 months
    Title
    Duodenal adenoma size.
    Time Frame
    6 months
    Title
    Curcumin and curcuminoid levels in blood.
    Time Frame
    6 months
    Title
    Curcumin and curcuminoid levels in urine.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Naomi Fliss, MSc
    Phone
    97236974458
    Email
    naomifl@tlvmc.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sivan Kaspi, RD
    Phone
    97236974458
    Email
    sivanah@tlvmc.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Revital Kariv, MD
    Organizational Affiliation
    Tel Aviv SMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16757216
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12050094
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22953026
    Citation
    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.
    Results Reference
    background

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

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