Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
NCT ID: NCT00020995
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-08-31
2010-01-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
Interventions
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therapeutic dietary intervention
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of adenocarcinoma of the prostate
* Previously untreated and on watchful waiting
* Medically able to receive dietary intervention
PATIENT CHARACTERISTICS:
Age:
* 40 to 80
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Must be willing to travel to UCLA 3 days a week for 4 weeks to obtain specially prepared foods
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* No concurrent luteinizing hormone-releasing hormone agonists (leuprolide or goserelin)
* No concurrent androgen-receptor blocking agents (flutamide or bicalutamide)
* No concurrent testosterone
* No concurrent insulin
* No concurrent finasteride
Radiotherapy:
* Not specified
Surgery:
* No prior orchiectomy
Other:
* No concurrent saw palmetto supplement
40 Years
80 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Principal Investigators
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William Aronson, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Locations
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Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Countries
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References
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Aronson WJ, Barnard RJ, Freedland SJ, Henning S, Elashoff D, Jardack PM, Cohen P, Heber D, Kobayashi N. Growth inhibitory effect of low fat diet on prostate cancer cells: results of a prospective, randomized dietary intervention trial in men with prostate cancer. J Urol. 2010 Jan;183(1):345-50. doi: 10.1016/j.juro.2009.08.104.
Other Identifiers
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UCLA-0001030
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1973
Identifier Type: -
Identifier Source: secondary_id
CDR0000068737
Identifier Type: -
Identifier Source: org_study_id