Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049309
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2002-11-12
Brief Title:
Low-Fat Diet andor Flaxseed in Preventing Prostate Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Prostate Cancer Impact Of Fat And Flaxseed - Modified Diets
Status:
COMPLETED
Status Verified Date:
2013-02
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 diet that is low in fat andor high in flaxseed may slow or prevent disease progression of prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of a diet that is low in fat andor high in flaxseed in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of a diet that is low in fat andor high in flaxseed in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer
Detailed Description:
OBJECTIVES
Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat- andor flaxseed-modified diets
Compare differences in histopathological markers associated with prostate cancer rates of apoptosis extent of high-grade prostatic intraepithelial neoplasia among patients in these diet groups
Compare changes in serum prostate specific antigen among patients in these diet groups
Compare changes in hormone-related factors total serum testosterone and free androgen index insulin-like growth factor IGF and IGF-binding protein-3 among patients in these diet groups
Compare the effects of diet on nutritional biomarkers levels of lignans in the urine and ejaculate fatty acid profiles of erythrocytes and prostatic tissue in these patients
Determine associations between dietary modification and changes in dietary biomarkers hormonal intermediates and study endpoints in these patients
OUTLINE This is a randomized study Patients are stratified according to Gleason score less than 7 vs at least 7 and race black vs non-black Patients are randomized to 1 of 4 diet groups
Arm I Flaxseed-supplemented diet Patients are instructed to incorporate ground flaxseed into their daily diets
Arm II Low-fat diet Patients are instructed on ways to achieve a diet with no greater than 20 of total energy from dietary fat
Arm III Flaxseed-supplemented low-fat diet Patients are instructed as in arm I and arm II
Arm IV Control diet Patients are contacted weekly but do not receive dietary counseling until after surgery
All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery After surgery all patients receive dietary counseling
PROJECTED ACCRUAL A total of 160 patients 40 per treatment arm will be accrued for this study
Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat- andor flaxseed-modified diets
Compare differences in histopathological markers associated with prostate cancer rates of apoptosis extent of high-grade prostatic intraepithelial neoplasia among patients in these diet groups
Compare changes in serum prostate specific antigen among patients in these diet groups
Compare changes in hormone-related factors total serum testosterone and free androgen index insulin-like growth factor IGF and IGF-binding protein-3 among patients in these diet groups
Compare the effects of diet on nutritional biomarkers levels of lignans in the urine and ejaculate fatty acid profiles of erythrocytes and prostatic tissue in these patients
Determine associations between dietary modification and changes in dietary biomarkers hormonal intermediates and study endpoints in these patients
OUTLINE This is a randomized study Patients are stratified according to Gleason score less than 7 vs at least 7 and race black vs non-black Patients are randomized to 1 of 4 diet groups
Arm I Flaxseed-supplemented diet Patients are instructed to incorporate ground flaxseed into their daily diets
Arm II Low-fat diet Patients are instructed on ways to achieve a diet with no greater than 20 of total energy from dietary fat
Arm III Flaxseed-supplemented low-fat diet Patients are instructed as in arm I and arm II
Arm IV Control diet Patients are contacted weekly but do not receive dietary counseling until after surgery
All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery After surgery all patients receive dietary counseling
PROJECTED ACCRUAL A total of 160 patients 40 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000258042 | OTHER | NCI | None |
| DUMC-1385-02-7R3ER | None | None | None |
| NCI-P02-0235 | None | None | None |
| CCUM-0202 | None | None | None |
| UMCC-0202 | None | None | None |