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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Chitosan

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion:

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.
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.
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
Able to swallow and retain oral medication
ECOG performance status of 0 - 2
Ability to sign written informed consent
Testosterone level <50ng/dL at time of enrollment.
Age 18 or older.
May have had prior radiation therapy, surgery, or cryoablation for primary prostate cancer
May have had prior cytotoxic chemotherapy for metastatic prostate cancer, prior treatment with genomically-targeted agents, or Provenge

Exclusion:

Known allergy to chitosan or shellfish.
History of receiving more than 2 classes of ADT.
Chronic constipation (BM < 3x weekly), history of malabsorption or history of daily laxative use.
Patients requiring medication administration with lunch or dinner or at a frequency of three or more times per day are not eligible.
Current use of chitosan, sevelamer, and/or glucosamine.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chitosan dose escalation

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) of Chitosan in PCa subjects.

Secondary Outcome Measures

Change in redox status (RedoxSys, serum oxidized glutathione)

Change in inflammation (plasma cytokines, Toll-like receptor signaling)

Change in insulin resistance (HOMA-IR)

Changes in bowel permeability (plasma endotoxin)

Changes in microbiome diversity (16s rDNA sequencing)

Correlate changes in serum AGE levels (pan-AGE, carboxymethyllysine, methylglyoxal

Measure the frequency of a > 30% reduction in total AGE levels from the pretreatment level.

Full Information

NCT ID

NCT03712371

First Posted

October 15, 2018

Last Updated

December 10, 2021

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT03712371

Brief Title

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

Official Title

Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

Interim study results were not favorable to continue with further enrollment.

Study Start Date

January 16, 2019 (Actual)

Primary Completion Date

July 2, 2020 (Actual)

Study Completion Date

September 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chitosan dose escalation

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Chitosan

Intervention Description

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 Measure Information:

Title

Maximum tolerated dose (MTD) of Chitosan in PCa subjects.

Time Frame

112 days

Secondary Outcome Measure Information:

Title

Change in redox status (RedoxSys, serum oxidized glutathione)

Time Frame

112 days

Title

Change in inflammation (plasma cytokines, Toll-like receptor signaling)

Time Frame

112 days

Title

Change in insulin resistance (HOMA-IR)

Time Frame

112 days

Title

Changes in bowel permeability (plasma endotoxin)

Time Frame

112 days

Title

Changes in microbiome diversity (16s rDNA sequencing)

Time Frame

112 days

Title

Correlate changes in serum AGE levels (pan-AGE, carboxymethyllysine, methylglyoxal

Time Frame

112 days

Title

Measure the frequency of a > 30% reduction in total AGE levels from the pretreatment level.

Time Frame

112 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: 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. 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. 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 Able to swallow and retain oral medication ECOG performance status of 0 - 2 Ability to sign written informed consent Testosterone level <50ng/dL at time of enrollment. Age 18 or older. May have had prior radiation therapy, surgery, or cryoablation for primary prostate cancer May have had prior cytotoxic chemotherapy for metastatic prostate cancer, prior treatment with genomically-targeted agents, or Provenge Exclusion: Known allergy to chitosan or shellfish. History of receiving more than 2 classes of ADT. Chronic constipation (BM < 3x weekly), history of malabsorption or history of daily laxative use. Patients requiring medication administration with lunch or dinner or at a frequency of three or more times per day are not eligible. Current use of chitosan, sevelamer, and/or glucosamine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Micheal Lilly, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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