Trials / Terminated
TerminatedNCT03712371
Study of Chitosan for Pharmacologic Manipulation of AGE Levels in Prostate Cancer Patients
Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Medical University of South Carolina · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Chitosan | Increasing dose levels from 500mg twice daily to 2000mg twice daily for up to 85 days. |
Timeline
- Start date
- 2019-01-16
- Primary completion
- 2020-07-02
- Completion
- 2021-09-07
- First posted
- 2018-10-19
- Last updated
- 2025-06-10
- Results posted
- 2025-06-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03712371. Inclusion in this directory is not an endorsement.