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

Phase 1

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Chitosan Dose Escalation	Chitosan	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.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose as Assessed by Number of Participants Who Experienced a Dose Limiting Toxicity	112 days	The maximum tolerated dose is defined as the dose that produces no more than 1 dose-limiting toxicity (DLT)in 6 subjects. Per protocol a DLT is defined as Grade 3 or higher hypophosphatemia and/ or Grade 3 or higher of any of the following toxicities, that the investigator deems related to chitosan, that do not improve or resolve within 7 days of onset: flatulence, increased stool bulkiness, bloating, nausea, heartburn

Secondary Outcome Measures

Name	Time	Method
Changes in Microbiome Diversity (16s rDNA Sequencing)	112 days	No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Correlate Changes in Serum AGE Levels (Pan-AGE, Carboxymethyllysine, Methylglyoxal	112 days	No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measure the Frequency of a > 30% Reduction in Total AGE Levels From the Pretreatment Level.	112 days	No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Change in Redox Status (RedoxSys, Serum Oxidized Glutathione)	112 days	No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Change in Inflammation (Plasma Cytokines, Toll-like Receptor Signaling)	112 days	No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Change in Insulin Resistance (HOMA-IR)	112 days	No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Changes in Bowel Permeability (Plasma Endotoxin)	112 days	No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.

Locations (1): Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States