| February 3, 2009 |
| February 3, 2009 |
| January 2006 |
| December 2009 (final data collection date for primary outcome measure) |
| fat acid ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
| |
| |
| |
| Low-Fat Diet and Omega-Fatty Acids for Prostate Cancer Prevention |
| Low-Fat Diet and Omega-Fatty Acids for Prostate Cancer Prevention |
Men who are scheduled for radical prostatectomy are considered candidates for this study. Six weeks prior to surgery, the subject will undergo screening procedures to determine eligibility. If eligible, the subject will be randomized to one of two four-week nutrition programs - either a balanced Western Diet or a low-fat diet with fish oil capsules. The UCLA GCRC (General Clinical Research Center) chefs will prepare breakfast, lunch, and dinner, and meals will be delivered to subjects in coolers two days per week. Subjects will require a minimum of four visits to the UCLA GCRC. |
Experiments have shown that a low fat diet high in fish oil may prevent the progression of prostate cancer. The purpose of this study is to determine if a low-fat diet combined with fish oil capsules will change the chemical substances present in blood and prostate tissue that are related to the growth of cancer cells. This study will compare how these substances are affected by either, a typical high-fat Western diet, or a low-fat diet combined with fish oil. |
| |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment |
| Prostate Cancer |
- Dietary Supplement: Western Diet
- Dietary Supplement: Low-fat diet
|
- Experimental: Subjects assigned to this arm will receive a western diet which will be prepared by UCLA's General Clinical Research Center and delivered 2 to 3 times per week.
- Experimental: A low-fat diet with fish oil capsules will be assigned to patients which will be prepared by General Clinical Research Center and delivered 2 to 3 times per week. In addition, this group will be asked to take 5 fish oil capsules per day.
|
| |
| |
| Recruiting |
| 70 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Has been diagnosed with adenocarcinoma (cancer)
- Able to sign the consents to participate.
- Is medically able to receive and comply with the dietary intervention.
- Accessible geographically and by telephone for nutritional counseling and follow up.
- Has elected to undergo radical prostatectomy.
- Agrees to stop taking dietary or vitamin supplements (Lycopene, Vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto, PC-SPES) for 1 week prior to starting the study.
- Can safely stop taking aspirin, COX-2 inhibitors, and other anti-inflammatory medications for 1 week prior to starting the study.
- Can safely stop taking fish oil capsules 2-weeks prior to starting the diet intervention.
Exclusion Criteria:
- Is taking LHRH agonists, androgen receptor blocking agents or finasteride.
- Has undergone bilateral orchiectomy.
- Has a bleeding disorder.
|
| Male |
| 40 Years to 75 Years |
| No |
|
|
| United States |
| |
| NCT00836615 |
| William Aronson, MD, University of California, Los Angeles |
| 01-07-026-14, P50 CA 92131-01A1 |
| University of California, Los Angeles |
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
|
| Principal Investigator: |
William Aronson, MD |
University of California, Los Angeles |
|
|
| University of California, Los Angeles |
| February 2009 |
