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

Sponsor
Medical University of South Carolina (Other)
Overall Status
Terminated
CT.gov ID
NCT03712371
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
31.7
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
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 :
Jan 16, 2019
Actual Primary Completion Date :
Jul 2, 2020
Actual Study Completion Date :
Sep 7, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose (MTD) of Chitosan in PCa subjects. [112 days]

Secondary Outcome Measures

  1. Change in redox status (RedoxSys, serum oxidized glutathione) [112 days]

  2. Change in inflammation (plasma cytokines, Toll-like receptor signaling) [112 days]

  3. Change in insulin resistance (HOMA-IR) [112 days]

  4. Changes in bowel permeability (plasma endotoxin) [112 days]

  5. Changes in microbiome diversity (16s rDNA sequencing) [112 days]

  6. Correlate changes in serum AGE levels (pan-AGE, carboxymethyllysine, methylglyoxal [112 days]

  7. Measure the frequency of a > 30% reduction in total AGE levels from the pretreatment level. [112 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion:

  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 Cockgroft and Gault formula

  • Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5x ULN

  1. Able to swallow and retain oral medication

  2. ECOG performance status of 0 - 2

  3. Ability to sign written informed consent

  4. Testosterone level <50ng/dL at time of enrollment.

  5. Age 18 or older.

  6. May have had prior radiation therapy, surgery, or cryoablation for primary prostate cancer

  7. May have had prior cytotoxic chemotherapy for metastatic prostate cancer, prior treatment with genomically-targeted agents, or Provenge

Exclusion:

  1. Known allergy to chitosan or shellfish.

  2. History of receiving more than 2 classes of ADT.

  3. Chronic constipation (BM < 3x weekly), history of malabsorption or history of daily laxative use.

  4. Patients requiring medication administration with lunch or dinner or at a frequency of three or more times per day are not eligible.

  5. Current use of chitosan, sevelamer, and/or glucosamine.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

  • Principal Investigator: Micheal Lilly, MD, Medical University of South Carolina

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT03712371
Other Study ID Numbers:
  • 102928
First Posted:
Oct 19, 2018
Last Update Posted:
Dec 15, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms
Chitosan

Study Results

No Results Posted as of Dec 15, 2021