Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-31 @ 5:04 AM
Study NCT ID:
NCT00020995
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2001-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Effects of a Low Fat Diet on Serum Factors and Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet with that of a standard diet in treating patients who have prostate cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet with that of a standard diet in treating patients who have prostate cancer.
Detailed Description:
OBJECTIVES:
* Compare the inhibition of growth of human prostate cancer cell lines by serum from patients with prostate cancer before and after being fed a low fat, high fiber diet.
* Determine the underlying mechanism through which a low fat, high fiber diet affects the growth of prostate cancer cell lines.
* Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell lines through androgen-dependent and/or androgen- independent mechanisms in these patients.
* Determine the growth factors, hormones, and/or binding proteins that may be responsible for affecting the growth of prostate cancer cell lines in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.
* Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.
* Arm II: Patients receive a control diet containing the standard amounts of fat and fiber.
PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within 6 months.
* Compare the inhibition of growth of human prostate cancer cell lines by serum from patients with prostate cancer before and after being fed a low fat, high fiber diet.
* Determine the underlying mechanism through which a low fat, high fiber diet affects the growth of prostate cancer cell lines.
* Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell lines through androgen-dependent and/or androgen- independent mechanisms in these patients.
* Determine the growth factors, hormones, and/or binding proteins that may be responsible for affecting the growth of prostate cancer cell lines in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.
* Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.
* Arm II: Patients receive a control diet containing the standard amounts of fat and fiber.
PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within 6 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: