Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003367
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Diet and PSA Levels in Patients With Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
The Effect of a Low Fat Diet High in Soy Fruits Vegetables Green Tea Vitamin E and Fiber on the PSA in Patients With Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 The amount of fat fiber soy fruits vegetables vitamin E and green tea in the diet may affect androgen metabolism in men This may affect PSA level in patients with prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two diets differing in fat fiber soy fruit vegetable vitamin E and green tea content in affecting PSA level in patients with prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two diets differing in fat fiber soy fruit vegetable vitamin E and green tea content in affecting PSA level in patients with prostate cancer
Detailed Description:
OBJECTIVES I Determine the effects of 2 dietary regimens on levels of prostate-specific antigen PSA in patients with prostate cancer II Determine the compliance of these patients with the dietary regimen III Evaluate the effects of the dietary regimen on quality of life in these patients IV Evaluate the effects of the dietary regimen on PSA anxiety in these patients V Evaluate the effects of the dietary regimen on obesity high blood pressure and serum cholesterol in these patients
OUTLINE This is a randomized study Patients are stratified according to previous treatment prostatectomy vs radiotherapy and prostate-specific antigen PSA level less than 5 mgmL vs 5 or greater mgmL All patients complete quality of life dietary and other questionnaires before during and at the conclusion of the study Patients are randomized to one of two dietary intervention regimens Arm I Intensive Nutritional Intervention Patients are assigned to follow a low fat high fiber diet that is also high in soy fruits and vegetables green tea and vitamin E Patients meet with a nutritionist for nutrition education and dietary counseling weekly for 8 weeks then every 2 weeks for 2 months and then monthly for 14 months Sessions include dietary counseling meal planning and instruction in skills necessary to maintain dietary lifestyle changes Patients record their dietary intake on a regular basis Arm II General Nutritional Instruction Patients are assigned to follow dietary guidelines established by the National Cancer Institute Patients meet with a nutritionist for dietary counseling and monitoring every 2 months for 18 months Patients on both arms have PSA levels tested before the study 1 and 3 months into the study and then every 3 months thereafter for up to 18 months
PROJECTED ACCRUAL A total of 154 patients will be accrued for this study over 2 years
OUTLINE This is a randomized study Patients are stratified according to previous treatment prostatectomy vs radiotherapy and prostate-specific antigen PSA level less than 5 mgmL vs 5 or greater mgmL All patients complete quality of life dietary and other questionnaires before during and at the conclusion of the study Patients are randomized to one of two dietary intervention regimens Arm I Intensive Nutritional Intervention Patients are assigned to follow a low fat high fiber diet that is also high in soy fruits and vegetables green tea and vitamin E Patients meet with a nutritionist for nutrition education and dietary counseling weekly for 8 weeks then every 2 weeks for 2 months and then monthly for 14 months Sessions include dietary counseling meal planning and instruction in skills necessary to maintain dietary lifestyle changes Patients record their dietary intake on a regular basis Arm II General Nutritional Instruction Patients are assigned to follow dietary guidelines established by the National Cancer Institute Patients meet with a nutritionist for dietary counseling and monitoring every 2 months for 18 months Patients on both arms have PSA levels tested before the study 1 and 3 months into the study and then every 3 months thereafter for up to 18 months
PROJECTED ACCRUAL A total of 154 patients will be accrued for this study over 2 years
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 |
|---|---|---|---|
| NCI-G98-1445 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066354 | REGISTRY | None | None |