Prostate CancerNCT00798876
Low-Fat Fish Oil Diet for Prostate Cancer Prevention
A study testing Fish Oil, Vitamin E supplement and Western Diet in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Fish Oil, Vitamin E supplement and Western Diet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2001to 12 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Los Angeles VA
Los Angeles, California, 90073
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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.
- Conditions
- Prostate Cancer
- Being tested
- Fish Oil, Vitamin E supplement, Western Diet, Low-Fat Diet, Medical Examination
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.
Vitamin E supplementDietary supplement
Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.
Western DietDietary supplement
Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.
Low-Fat DietDietary supplement
Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.
Medical ExaminationOther
Subjects will have a routine medical exam.
Dietary InterviewOther
Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.
Blood DrawOther
40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.
Radical ProstatectomyProcedure or surgery
Subjects will undergo a radical prostatectomy as part of their standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard Western Diet | Placebo comparator | Subjects will be asked to consume a standard Western Diet for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care). Receives: Dietary Supplement: Western Diet; Other: Medical Examination; Other: Dietary Interview; Other: Blood Draw; Procedure: Radical Prostatectomy |
| Low-Fat Diet | Experimental | Subjects will be asked to consume a low fat diet with fish oil and vitamin E supplements for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care). Receives: Dietary Supplement: Fish Oil; Dietary Supplement: Vitamin E supplement; Dietary Supplement: Low-Fat Diet; Other: Medical Examination; Other: Dietary Interview; Other: Blood Draw; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
check for insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer
Measured: 4 weeks
Secondary outcomes (1)
Check serum and tissue fatty acids as relevant intermediate biomarkers for prostate cancer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study start18 Dec 2001
- Primary completion12 Feb 2018
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William Aronson, MD, Principal investigator, UCLA and Western Los Angles VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798876
- Sponsor's protocol ID
- 01-07-026
- Other IDs
- P50CA092131-01A1, 11-002610
- Status last verified
- May 2019
- First submitted
- 25 Nov 2008
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics, 1999. CA Cancer J Clin. 1999 Jan-Feb;49(1):8-31, 1. doi: 10.3322/canjclin.49.1.8.
PubMed 10200775Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin. 1999 Jan-Feb;49(1):33-64, 1. doi: 10.3322/canjclin.49.1.33.
PubMed 10200776Muir CS, Nectoux J, Staszewski J. The epidemiology of prostatic cancer. Geographical distribution and time-trends. Acta Oncol. 1991;30(2):133-40. doi: 10.3109/02841869109092336.
PubMed 2029395Yatani R, Kusano I, Shiraishi T, Hayashi T, Stemmermann GN. Latent prostatic carcinoma: pathological and epidemiological aspects. Jpn J Clin Oncol. 1989 Dec;19(4):319-26.
PubMed 2691730Shimizu H, Ross RK, Bernstein L, Yatani R, Henderson BE, Mack TM. Cancers of the prostate and breast among Japanese and white immigrants in Los Angeles County. Br J Cancer. 1991 Jun;63(6):963-6. doi: 10.1038/bjc.1991.210.
PubMed 2069852Stellman SD, Wang QS. Cancer mortality in Chinese immigrants to New York City. Comparison with Chinese in Tianjin and with United States-born whites. Cancer. 1994 Feb 15;73(4):1270-5. doi: 10.1002/1097-0142(19940215)73:43.0.co;2-y.
PubMed 8313330Cook LS, Goldoft M, Schwartz SM, Weiss NS. Incidence of adenocarcinoma of the prostate in Asian immigrants to the United States and their descendants. J Urol. 1999 Jan;161(1):152-5.
PubMed 10037388Whittemore AS, Kolonel LN, Wu AH, John EM, Gallagher RP, Howe GR, Burch JD, Hankin J, Dreon DM, West DW, et al. Prostate cancer in relation to diet, physical activity, and body size in blacks, whites, and Asians in the United States and Canada. J Natl Cancer Inst. 1995 May 3;87(9):652-61. doi: 10.1093/jnci/87.9.652.
PubMed 7752270Boyle P, Levi F, Lucchini F, La Vecchia C, Kevi R [corrected to Levi F], Lucchuni F [corrected to Lucchini F]. Trends in diet-related cancers in Japan: a conundrum? Lancet. 1993 Sep 18;342(8873):752. doi: 10.1016/0140-6736(93)91748-b. No abstract available.
PubMed 8103867Wynder EL, Fujita Y, Harris RE, Hirayama T, Hiyama T. Comparative epidemiology of cancer between the United States and Japan. A second look. Cancer. 1991 Feb 1;67(3):746-63. doi: 10.1002/1097-0142(19910201)67:33.0.co;2-1.
PubMed 1985768Giovannucci E, Rimm EB, Colditz GA, Stampfer MJ, Ascherio A, Chute CG, Willett WC. A prospective study of dietary fat and risk of prostate cancer. J Natl Cancer Inst. 1993 Oct 6;85(19):1571-9. doi: 10.1093/jnci/85.19.1571.
PubMed 8105097West DW, Slattery ML, Robison LM, French TK, Mahoney AW. Adult dietary intake and prostate cancer risk in Utah: a case-control study with special emphasis on aggressive tumors. Cancer Causes Control. 1991 Mar;2(2):85-94. doi: 10.1007/BF00053126.
PubMed 1873441Kolonel LN, Yoshizawa CN, Hankin JH. Diet and prostatic cancer: a case-control study in Hawaii. Am J Epidemiol. 1988 May;127(5):999-1012. doi: 10.1093/oxfordjournals.aje.a114903.
PubMed 3358418Fradet Y, Meyer F, Bairati I, Shadmani R, Moore L. Dietary fat and prostate cancer progression and survival. Eur Urol. 1999;35(5-6):388-91. doi: 10.1159/000019913.
PubMed 10325493Wang Y, Corr JG, Thaler HT, Tao Y, Fair WR, Heston WD. Decreased growth of established human prostate LNCaP tumors in nude mice fed a low-fat diet. J Natl Cancer Inst. 1995 Oct 4;87(19):1456-62. doi: 10.1093/jnci/87.19.1456.
PubMed 7545759
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of a Low-Fat Diet Supplemented With Fish Oil and a Standard Western Diet in Individuals With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00798876
- Acronym / sponsor ID
- 01-07-026
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Dec 2001 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Western Diet | Placebo comparator | Dietary Supplement: Western Diet, Other: Medical Examination, Other: Dietary Interview, Other: Blood Draw, Procedure: Radical ProstatectomySubjects will be asked to consume a standard Western Diet for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care). |
| Low-Fat Diet | Experimental | Dietary Supplement: Fish Oil, Dietary Supplement: Vitamin E supplement, Dietary Supplement: Low-Fat Diet, Other: Medical Examination, Other: Dietary Interview, Other: Blood Draw, Procedure: Radical ProstatectomySubjects will be asked to consume a low fat diet with fish oil and vitamin E supplements for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilSubjects will be asked to take 10 grams of fish oil per day for 4 weeks. | Dietary supplement | Low-Fat Diet |
| Vitamin E supplementSubjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks. | Dietary supplement | Low-Fat Diet |
| Western DietSubjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study. | Dietary supplement | Standard Western Diet |
| Low-Fat DietSubjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study. | Dietary supplement | Low-Fat Diet |
| Medical ExaminationSubjects will have a routine medical exam. | Other | Low-Fat Diet, Standard Western Diet |
| Dietary InterviewSubjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat. | Other | Low-Fat Diet, Standard Western Diet |
| Blood Draw40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones. | Other | Low-Fat Diet, Standard Western Diet |
| Radical ProstatectomySubjects will undergo a radical prostatectomy as part of their standard of care. | Procedure or surgery | Low-Fat Diet, Standard Western Diet |
Primary outcome
check for insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer
Time frame: 4 weeks
1 secondary outcome
Check serum and tissue fatty acids as relevant intermediate biomarkers for prostate cancer
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 10200775Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics, 1999. CA Cancer J Clin. 1999 Jan-Feb;49(1):8-31, 1. doi: 10.3322/canjclin.49.1.8.
- Background: PubMed 10200776Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin. 1999 Jan-Feb;49(1):33-64, 1. doi: 10.3322/canjclin.49.1.33.
- Background: PubMed 2029395Muir CS, Nectoux J, Staszewski J. The epidemiology of prostatic cancer. Geographical distribution and time-trends. Acta Oncol. 1991;30(2):133-40. doi: 10.3109/02841869109092336.
- Background: PubMed 2691730Yatani R, Kusano I, Shiraishi T, Hayashi T, Stemmermann GN. Latent prostatic carcinoma: pathological and epidemiological aspects. Jpn J Clin Oncol. 1989 Dec;19(4):319-26.
- Background: PubMed 2069852Shimizu H, Ross RK, Bernstein L, Yatani R, Henderson BE, Mack TM. Cancers of the prostate and breast among Japanese and white immigrants in Los Angeles County. Br J Cancer. 1991 Jun;63(6):963-6. doi: 10.1038/bjc.1991.210.
- Background: PubMed 8313330Stellman SD, Wang QS. Cancer mortality in Chinese immigrants to New York City. Comparison with Chinese in Tianjin and with United States-born whites. Cancer. 1994 Feb 15;73(4):1270-5. doi: 10.1002/1097-0142(19940215)73:43.0.co;2-y.
- Background: PubMed 10037388Cook LS, Goldoft M, Schwartz SM, Weiss NS. Incidence of adenocarcinoma of the prostate in Asian immigrants to the United States and their descendants. J Urol. 1999 Jan;161(1):152-5.
- Background: PubMed 7752270Whittemore AS, Kolonel LN, Wu AH, John EM, Gallagher RP, Howe GR, Burch JD, Hankin J, Dreon DM, West DW, et al. Prostate cancer in relation to diet, physical activity, and body size in blacks, whites, and Asians in the United States and Canada. J Natl Cancer Inst. 1995 May 3;87(9):652-61. doi: 10.1093/jnci/87.9.652.
- Background: PubMed 8103867Boyle P, Levi F, Lucchini F, La Vecchia C, Kevi R [corrected to Levi F], Lucchuni F [corrected to Lucchini F]. Trends in diet-related cancers in Japan: a conundrum? Lancet. 1993 Sep 18;342(8873):752. doi: 10.1016/0140-6736(93)91748-b. No abstract available.
- Background: PubMed 1985768Wynder EL, Fujita Y, Harris RE, Hirayama T, Hiyama T. Comparative epidemiology of cancer between the United States and Japan. A second look. Cancer. 1991 Feb 1;67(3):746-63. doi: 10.1002/1097-0142(19910201)67:33.0.co;2-1.
- Background: PubMed 8105097Giovannucci E, Rimm EB, Colditz GA, Stampfer MJ, Ascherio A, Chute CG, Willett WC. A prospective study of dietary fat and risk of prostate cancer. J Natl Cancer Inst. 1993 Oct 6;85(19):1571-9. doi: 10.1093/jnci/85.19.1571.
- Background: PubMed 1873441West DW, Slattery ML, Robison LM, French TK, Mahoney AW. Adult dietary intake and prostate cancer risk in Utah: a case-control study with special emphasis on aggressive tumors. Cancer Causes Control. 1991 Mar;2(2):85-94. doi: 10.1007/BF00053126.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Aronson, MD principal investigator
UCLA and Western Los Angles VA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil, Vitamin E supplement and Western Diet in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
check for insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00798876, which also lists 70 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.