Low-Fat Fish Oil Diet for Prostate Cancer Prevention
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | December 2001 |
Comparison Study of a Low-Fat Diet Supplemented With Fish Oil and a Standard Western Diet in Individuals With Prostate Cancer
Studies on patterns of how many men get prostate cancer in other countries show that
environment contributes to the high incidence of prostate cancer in the United States.
Epidemiology studies suggest that this influence may be reduced by the diet of men at risk
of getting prostate cancer. Although the exact nature of the effects of diet are not
completely known, the amount of fat eaten appears to affect the number of men who get
prostate cancer. The type of fat also seems to matter. Eating more of a type of fat called
omega-3 polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat
comes from fish and is quite different from the type of fat from animals and vegetables
(omega-6 fat). Because the exact mechanism of this reduction in prostate cancer risk is not
known, no blood test indications, called markers, have been discovered that would show the
effect working.
Study doctors designed this study to try to find markers in the blood tests of men who have
prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil
helps reduce those markers, hence indicating that it helps reduce the cancer in these men.
These men will be compared to men with prostate cancer whose diets do not contain the
fish-oil fat.
The men chosen will have prostate cancer and be scheduled for operations to have their
prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a
regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the
beginning of the diet. After the 4-to-8-week period, they will have their operations. Their
blood will be checked again and a sample of their removed prostate will be examined to tell
if the diet had any effect on the cancer and its markers.
environment contributes to the high incidence of prostate cancer in the United States.
Epidemiology studies suggest that this influence may be reduced by the diet of men at risk
of getting prostate cancer. Although the exact nature of the effects of diet are not
completely known, the amount of fat eaten appears to affect the number of men who get
prostate cancer. The type of fat also seems to matter. Eating more of a type of fat called
omega-3 polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat
comes from fish and is quite different from the type of fat from animals and vegetables
(omega-6 fat). Because the exact mechanism of this reduction in prostate cancer risk is not
known, no blood test indications, called markers, have been discovered that would show the
effect working.
Study doctors designed this study to try to find markers in the blood tests of men who have
prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil
helps reduce those markers, hence indicating that it helps reduce the cancer in these men.
These men will be compared to men with prostate cancer whose diets do not contain the
fish-oil fat.
The men chosen will have prostate cancer and be scheduled for operations to have their
prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a
regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the
beginning of the diet. After the 4-to-8-week period, they will have their operations. Their
blood will be checked again and a sample of their removed prostate will be examined to tell
if the diet had any effect on the cancer and its markers.
1. To establish and validate intermediate biomarkers for prostate cancer prevention trials
by conducting a dietary intervention trial of a low-fat diet with omega-3 fatty acid
supplements in men undergoing radical prostatectomy. In initial trials it was feasible
to intervene with diet and obtain tissue and serum for bioassay and biomarker
development. This aim is to study the effect a low-fat, high omega-3 diet has on serum
and tissue biomarkers from patients who have prostatectomies for prostate cancer.
Ultimately, we hope to identify and validate intermediate markers of efficacy for
large-scale dietary prevention trials.
2. To establish and validate insulin growth factor-1 (IGF-1) and insulin growth factor
binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer
prevention trials. IGF-1 is a peptide growth factor that is important to the growth and
progression of prostate cancer. To our knowledge, no prospective dietary intervention
studies have evaluated the effect of a low-fat diet with omega-3 fatty acid supplements
on IGF-1 and IGFBPs, and their potential to serve as relevant intermediate markers for
low-fat dietary intervention trials for prostate cancer prevention.
3. To establish and validate serum and tissue fatty acids as relevant intermediate
biomarkers for prostate cancer prevention trials. We will evaluate if men randomized to
a low-fat, fish-oil-supplemented diet have increased serum ratios of omega-3:omega-6
fatty acids compared with men randomized to a control Western diet before radical
prostatectomy. We also will study if patients in the low-fat, fish oil arm have
increased ratios of membrane omega-3:omega-6 fatty acids as well as decreased COX-2 and
decreased PGE-2 levels in benign and malignant tissue and in visceral fat. If so, it
will proved further evidence to support the potential of low-fat fish oil diets for
prostate cancer prevention. If serum omega-3:omega-6 ratios correlate with changes in
COX-2 and PGE-2 in tissues, then serum omea-3:omega-6 ratios may be useful for
monitoring activity and efficacy of low-fat fish-oil-supplemented diets in future
trials.
by conducting a dietary intervention trial of a low-fat diet with omega-3 fatty acid
supplements in men undergoing radical prostatectomy. In initial trials it was feasible
to intervene with diet and obtain tissue and serum for bioassay and biomarker
development. This aim is to study the effect a low-fat, high omega-3 diet has on serum
and tissue biomarkers from patients who have prostatectomies for prostate cancer.
Ultimately, we hope to identify and validate intermediate markers of efficacy for
large-scale dietary prevention trials.
2. To establish and validate insulin growth factor-1 (IGF-1) and insulin growth factor
binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer
prevention trials. IGF-1 is a peptide growth factor that is important to the growth and
progression of prostate cancer. To our knowledge, no prospective dietary intervention
studies have evaluated the effect of a low-fat diet with omega-3 fatty acid supplements
on IGF-1 and IGFBPs, and their potential to serve as relevant intermediate markers for
low-fat dietary intervention trials for prostate cancer prevention.
3. To establish and validate serum and tissue fatty acids as relevant intermediate
biomarkers for prostate cancer prevention trials. We will evaluate if men randomized to
a low-fat, fish-oil-supplemented diet have increased serum ratios of omega-3:omega-6
fatty acids compared with men randomized to a control Western diet before radical
prostatectomy. We also will study if patients in the low-fat, fish oil arm have
increased ratios of membrane omega-3:omega-6 fatty acids as well as decreased COX-2 and
decreased PGE-2 levels in benign and malignant tissue and in visceral fat. If so, it
will proved further evidence to support the potential of low-fat fish oil diets for
prostate cancer prevention. If serum omega-3:omega-6 ratios correlate with changes in
COX-2 and PGE-2 in tissues, then serum omea-3:omega-6 ratios may be useful for
monitoring activity and efficacy of low-fat fish-oil-supplemented diets in future
trials.
Eligibility Criteria:
- Patient consents to participate.
- Medically able to receive and comply with the diet.
- Lives near enough for counseling and follow-up.
- Has elected to have operation to remove prostate.
- Agrees to stop diet or vitamin supplements or herbal supplements for 1 week before
the study begins.
- Patient able to stop taking aspirin, COX-2 inhibitors, and other anti-inflammatory
medications for 1 week before study start.
- Patient able to safely stop taking fish oil capsules 2 weeks before the diet starts.
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