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

Phase 1

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Chitosan

• Registration Number: NCT03712371
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2019-01-16
• Primary Completion: 2020-07-02
• Study Completion: 2021-09-07
• Status Verified: 2021-12
• Disposition First Submitted: 2021-12-10
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chitosan dose escalation	Chitosan	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of Chitosan in PCa subjects.	112 days

Secondary Outcome Measures

Name	Time	Method
Changes in microbiome diversity (16s rDNA sequencing)	112 days
Change in inflammation (plasma cytokines, Toll-like receptor signaling)	112 days
Measure the frequency of a > 30% reduction in total AGE levels from the pretreatment level.	112 days
Change in redox status (RedoxSys, serum oxidized glutathione)	112 days
Change in insulin resistance (HOMA-IR)	112 days
Changes in bowel permeability (plasma endotoxin)	112 days
Correlate changes in serum AGE levels (pan-AGE, carboxymethyllysine, methylglyoxal	112 days

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States