Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082732
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2004-05-14
Brief Title:
Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-11
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 that includes soy protein may prevent disease progression in patients with hormone-refractory prostate cancer Nutrition counseling may help motivate patients to follow this diet
PURPOSE Randomized phase I trial to study the effectiveness of behavior-based dietary interventions such as receiving nutrition counseling in helping patients who have hormone-refractory prostate cancer follow a low-fat high-fiber soy-supplemented diet
PURPOSE Randomized phase I trial to study the effectiveness of behavior-based dietary interventions such as receiving nutrition counseling in helping patients who have hormone-refractory prostate cancer follow a low-fat high-fiber soy-supplemented diet
Detailed Description:
OBJECTIVES
Determine whether a behavior-based dietary intervention can motivate patients with hormone-refractory prostate cancer to adopt and maintain a dietary pattern that includes 20 of energy from fat 25 g of fiber and 80 g of soy protein powder
Compare bioavailable levels of testosterone in patients treated with a behavior-based dietary intervention vs observation only
Determine whether this dietary intervention decreases or stabilizes a rising serum prostate-specific antigen level in these patients
Determine whether this dietary intervention improves disease-specific survival mediated by reduced bioavailable levels of testosterone in these patients
Determine the impact of a positive intervention outcome on androgen receptors in patients treated with this dietary intervention
OUTLINE This is a randomized controlled pilot multicenter study Patients are randomized to 1 of 2 treatment arms
All patients receive nutritional counseling on a healthy diet Patients also keep a food diary during study participation
Arm I dietary intervention Patients receive dietary intervention comprising nutritional counseling on a low-fat high-fiber soy supplemented diet and behavior-based activities such as goal-setting contracting and stimulus control once weekly for 6 weeks every 3 weeks for 33 weeks and then at weeks 44 48 and 52 Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II observation Patients undergo observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks
PROJECTED ACCRUAL A total of 92 patients 46 per treatment arm will be accrued for this study
Determine whether a behavior-based dietary intervention can motivate patients with hormone-refractory prostate cancer to adopt and maintain a dietary pattern that includes 20 of energy from fat 25 g of fiber and 80 g of soy protein powder
Compare bioavailable levels of testosterone in patients treated with a behavior-based dietary intervention vs observation only
Determine whether this dietary intervention decreases or stabilizes a rising serum prostate-specific antigen level in these patients
Determine whether this dietary intervention improves disease-specific survival mediated by reduced bioavailable levels of testosterone in these patients
Determine the impact of a positive intervention outcome on androgen receptors in patients treated with this dietary intervention
OUTLINE This is a randomized controlled pilot multicenter study Patients are randomized to 1 of 2 treatment arms
All patients receive nutritional counseling on a healthy diet Patients also keep a food diary during study participation
Arm I dietary intervention Patients receive dietary intervention comprising nutritional counseling on a low-fat high-fiber soy supplemented diet and behavior-based activities such as goal-setting contracting and stimulus control once weekly for 6 weeks every 3 weeks for 33 weeks and then at weeks 44 48 and 52 Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II observation Patients undergo observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks
PROJECTED ACCRUAL A total of 92 patients 46 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 |
|---|---|---|---|
| DM98-054 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-98054 | None | None | None |