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Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT03712371
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
This study will examine the utility of chitosan for reduction of blood or tissue levels of AGEs in patients with prostate cancer who are clinically stable on androgen-deprivation therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Chitosan Phase 1 Phase 2

Detailed Description:
The overall goal of this study is to identify a safe dose of the metabolic supplement, Chitosan that can help reduce AGE (advanced glycation endproducts) levels in patients with prostate cancer. Chitosan is a naturally occurring substance found in shellfish. This study will be using Chitosan prepared from the shells of cold-water shrimp. Chitosan is approved by the FDA for use in wound dressings and has been used in published clinical trials for weight loss but is not approved for the purposes of this study. AGEs are a type of metabolite, or substance, found in food and produced in the body. The researchers helping conduct this study have found a potential link between AGE levels and cancer. Participation in this study will require three study visits over the course of about 3 months. During these visits subjects will be asked to provide blood and stool samples as well as complete surveys about their quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Chitosan dose escalation Drug: Chitosan
The starting dose for Chitosan is 500mg twice a day, the second dose level is 1000mg twice a day, the third dose level is 1500mg twice a day, and the fourth dose level is 2000mg twice a day. Each dose level lasts for 28 days.




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of Chitosan in PCa subjects. [ Time Frame: 112 days ]

Secondary Outcome Measures :
  1. Change in redox status (RedoxSys, serum oxidized glutathione) [ Time Frame: 112 days ]
  2. Change in inflammation (plasma cytokines, Toll-like receptor signaling) [ Time Frame: 112 days ]
  3. Change in insulin resistance (HOMA-IR) [ Time Frame: 112 days ]
  4. Changes in bowel permeability (plasma endotoxin) [ Time Frame: 112 days ]
  5. Changes in microbiome diversity (16s rDNA sequencing) [ Time Frame: 112 days ]
  6. Correlate changes in serum AGE levels (pan-AGE, carboxymethyllysine, methylglyoxal [ Time Frame: 112 days ]
  7. Measure the frequency of a > 30% reduction in total AGE levels from the pretreatment level. [ Time Frame: 112 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer.

2. Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen or testosterone synthesis inhibitor. The current testosterone level must be documented to be <50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain <50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible.

3. Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:

  • Hematology parameters: ANC >1000/mcL, platelets > 100,000/mcL, Hgb >8.0gm/dL
  • Renal Function: eGFR of ≥ 45mls/min using Cockkroft and Gault formula
  • Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5x ULN 4. Able to swallow and retain oral medication 5. ECOG performance status of 0 - 2 6. Ability to sign written informed consent 7. Testosterone level <50ng/dL at time of enrollment. 8. Age 18 or older. 9. May have had prior radiation therapy, surgery, or cryoablation for primary prostate cancer

    1. Known allergy to chitosan or shellfish.
    2. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
    3. History of receiving more than 2 classes of ADT.
    4. PSA doubling time of <6 months, measured over the 3 months prior to enrollment.
    5. Chronic constipation (BM < 3x weekly), history of malabsorption or history of daily laxative use.
    6. Patients requiring medication administration with lunch or dinner or at a frequency of three or more times per day are not eligible.

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): NCT03712371


Contacts
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Contact: Alan Brisendine 843-792-9007 hcc-clinical-trials@musc.edu
Contact: Micheal Lilly, MD 843-792-4271 lillym@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alan Brisendine    843-792-9007    hcc-clinical-trials@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Micheal Lilly, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03712371     History of Changes
Other Study ID Numbers: 102928
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants