Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020995
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2001-07-11
Brief Title:
Low-Fat High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
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 andor androgen- independent mechanisms in these patients
Determine the growth factors hormones andor 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 andor androgen- independent mechanisms in these patients
Determine the growth factors hormones andor 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1973 | None | None | None |
| UCLA-0001030 | None | None | None |