Study of Chitosan for Pharmacologic Manipulation of AGE Levels in Prostate Cancer Patients

NCT ID: NCT03712371

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2021-09-07

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chitosan Dose Escalation

The starting dose for Chitosan is 500mg twice daily, the second dose level is 1000mg twice daily, the third dose level is 1500mg twice daily and the fourth dose level is 2000mg twice daily. Safety evaluation is 28 days in length and total dose administration is 85 days in length.

Group Type: EXPERIMENTAL

Chitosan

Intervention Type: DRUG

Increasing dose levels from 500mg twice daily to 2000mg twice daily for up to 85 days.

Interventions

Chitosan

Increasing dose levels from 500mg twice daily to 2000mg twice daily for up to 85 days.

Intervention Type: DRUG

Eligibility 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 Cockgroft 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

10. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lilly, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

102928

Identifier Type: -

Identifier Source: org_study_id