Low-Fat Fish Oil Diet for Prostate Cancer Prevention

Prostate Cancer Clinical Trial

Official title:

Comparison Study of a Low-Fat Diet Supplemented With Fish Oil and a Standard Western Diet in Individuals With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798876
• Other study ID #: 01-07-026
• Secondary ID: P50CA092131-01A1
• Status: Completed
• Phase: N/A
• Start date: December 18, 2001
• Est. completion date: February 12, 2018

Study information

• Verified date: May 2019
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

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.

Other known NCT identifiers

• NCT00836615

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Fish Oil
Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.
• Vitamin E supplement
Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.
• Western Diet
Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.
• Low-Fat Diet
Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.

Other:
• Medical Examination
Subjects will have a routine medical exam.
• Dietary Interview
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 Draw
40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.

Procedure:
• Radical Prostatectomy
Subjects will undergo a radical prostatectomy as part of their standard of care.

Locations

Country	Name	City	State
United States	UCLA Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	West Los Angeles VA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (70)

Ablin RJ, Shaw MW. Prostaglandin modulation of prostate tumor growth and metastases. Anticancer Res. 1986 Mar-Apr;6(2):327-8. — View Citation

Bagga D, Capone S, Wang HJ, Heber D, Lill M, Chap L, Glaspy JA. Dietary modulation of omega-3/omega-6 polyunsaturated fatty acid ratios in patients with breast cancer. J Natl Cancer Inst. 1997 Aug 6;89(15):1123-31. — View Citation

Baghurst KI, Crawford DA, Worsley A, Record SJ. The Victorian Nutrition Survey--intakes and sources of dietary fats and cholesterol in the Victorian population. Med J Aust. 1988 Jul 4;149(1):12-5, 18-20. — View Citation

Boyle 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. Erratum in: Lancet 1993 Oct 16;342(8877):1000. — View Citation

Bucher C, Jordan P, Nickeleit V, Torhorst J, Mihatsch MJ. Relative risk of malignant tumors in analgesic abusers. Effects of long-term intake of aspirin. Clin Nephrol. 1999 Feb;51(2):67-72. — View Citation

Chan JM, Stampfer MJ, Giovannucci E, Gann PH, Ma J, Wilkinson P, Hennekens CH, Pollak M. Plasma insulin-like growth factor-I and prostate cancer risk: a prospective study. Science. 1998 Jan 23;279(5350):563-6. — View Citation

Cook 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. — View Citation

Culp BR, Titus BG, Lands WE. Inhibition of prostaglandin biosynthesis by eicosapentaenoic acid. Prostaglandins Med. 1979 Nov;3(5):269-78. — View Citation

Donaghy AJ, Baxter RC. Insulin-like growth factor bioactivity and its modification in growth hormone resistant states. Baillieres Clin Endocrinol Metab. 1996 Jul;10(3):421-46. Review. — View Citation

Dunn SE, Kari FW, French J, Leininger JR, Travlos G, Wilson R, Barrett JC. Dietary restriction reduces insulin-like growth factor I levels, which modulates apoptosis, cell proliferation, and tumor progression in p53-deficient mice. Cancer Res. 1997 Nov 1;57(21):4667-72. — View Citation

Feldman JM, Hilf R. A role of estrogens and insulin binding in the dietary lipid alteration of R3230AC mammary carcinoma growth in rats. Cancer Res. 1985 May;45(5):1964-72. — View Citation

Ferry RJ Jr, Katz LE, Grimberg A, Cohen P, Weinzimer SA. Cellular actions of insulin-like growth factor binding proteins. Horm Metab Res. 1999 Feb-Mar;31(2-3):192-202. Review. — View Citation

Fradet 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. Review. — View Citation

Giovannucci 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. Erratum in: J Natl Cancer Inst. 2013 Jul 3;105(13):944. Chute, C C [corrected to Chute, C G]. — View Citation

Godley PA, Campbell MK, Gallagher P, Martinson FE, Mohler JL, Sandler RS. Biomarkers of essential fatty acid consumption and risk of prostatic carcinoma. Cancer Epidemiol Biomarkers Prev. 1996 Nov;5(11):889-95. — View Citation

Grimberg A, Cohen P. Role of insulin-like growth factors and their binding proteins in growth control and carcinogenesis. J Cell Physiol. 2000 Apr;183(1):1-9. Review. — View Citation

Gupta S, Srivastava M, Ahmad N, Bostwick DG, Mukhtar H. Over-expression of cyclooxygenase-2 in human prostate adenocarcinoma. Prostate. 2000 Jan;42(1):73-8. — View Citation

Hansen HS. Dietary essential fatty acids and in vivo prostaglandin production in mammals. World Rev Nutr Diet. 1983;42:102-34. Review. — View Citation

Hsing AW, McLaughlin JK, Schuman LM, Bjelke E, Gridley G, Wacholder S, Chien HT, Blot WJ. Diet, tobacco use, and fatal prostate cancer: results from the Lutheran Brotherhood Cohort Study. Cancer Res. 1990 Nov 1;50(21):6836-40. — View Citation

Hwang D, Scollard D, Byrne J, Levine E. Expression of cyclooxygenase-1 and cyclooxygenase-2 in human breast cancer. J Natl Cancer Inst. 1998 Mar 18;90(6):455-60. — View Citation

Iwamura M, Sluss PM, Casamento JB, Cockett AT. Insulin-like growth factor I: action and receptor characterization in human prostate cancer cell lines. Prostate. 1993;22(3):243-52. — View Citation

Kaplan PJ, Mohan S, Cohen P, Foster BA, Greenberg NM. The insulin-like growth factor axis and prostate cancer: lessons from the transgenic adenocarcinoma of mouse prostate (TRAMP) model. Cancer Res. 1999 May 1;59(9):2203-9. — View Citation

Karmali RA. Eicosanoids in neoplasia. Prev Med. 1987 Jul;16(4):493-502. — View Citation

Kirschenbaum A, Klausner AP, Lee R, Unger P, Yao S, Liu XH, Levine AC. Expression of cyclooxygenase-1 and cyclooxygenase-2 in the human prostate. Urology. 2000 Oct 1;56(4):671-6. — View Citation

Kobayashi M, Sasaki S, Hamada GS, Tsugane S. Serum n-3 fatty acids, fish consumption and cancer mortality in six Japanese populations in Japan and Brazil. Jpn J Cancer Res. 1999 Sep;90(9):914-21. — View Citation

Kolonel LN, Yoshizawa CN, Hankin JH. Diet and prostatic cancer: a case-control study in Hawaii. Am J Epidemiol. 1988 May;127(5):999-1012. — View Citation

Kris-Etherton PM, Taylor DS, Yu-Poth S, Huth P, Moriarty K, Fishell V, Hargrove RL, Zhao G, Etherton TD. Polyunsaturated fatty acids in the food chain in the United States. Am J Clin Nutr. 2000 Jan;71(1 Suppl):179S-88S. doi: 10.1093/ajcn/71.1.179S. Review. — View Citation

Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics, 1999. CA Cancer J Clin. 1999 Jan-Feb;49(1):8-31, 1. — View Citation

Lepage G, Roy CC. Direct transesterification of all classes of lipids in a one-step reaction. J Lipid Res. 1986 Jan;27(1):114-20. — View Citation

Levy GN. Prostaglandin H synthases, nonsteroidal anti-inflammatory drugs, and colon cancer. FASEB J. 1997 Mar;11(4):234-47. Review. — View Citation

Magoha GA. Ten years experience with chronic prostatitis in Africans. East Afr Med J. 1996 Mar;73(3):176-8. — View Citation

Mantzoros CS, Tzonou A, Signorello LB, Stampfer M, Trichopoulos D, Adami HO. Insulin-like growth factor 1 in relation to prostate cancer and benign prostatic hyperplasia. Br J Cancer. 1997;76(9):1115-8. — View Citation

Marnett LJ. Prostaglandin synthase-mediated metabolism of carcinogens and a potential role for peroxyl radicals as reactive intermediates. Environ Health Perspect. 1990 Aug;88:5-12. Review. — View Citation

Mishina T, Watanabe H, Araki H, Nakao M. Epidemiological study of prostatic cancer by matched-pair analysis. Prostate. 1985;6(4):423-36. — View Citation

Muir CS, Nectoux J, Staszewski J. The epidemiology of prostatic cancer. Geographical distribution and time-trends. Acta Oncol. 1991;30(2):133-40. Review. — View Citation

Mukherjee P, Sotnikov AV, Mangian HJ, Zhou JR, Visek WJ, Clinton SK. Energy intake and prostate tumor growth, angiogenesis, and vascular endothelial growth factor expression. J Natl Cancer Inst. 1999 Mar 17;91(6):512-23. — View Citation

Nam SY, Lee EJ, Kim KR, Cha BS, Song YD, Lim SK, Lee HC, Huh KB. Effect of obesity on total and free insulin-like growth factor (IGF)-1, and their relationship to IGF-binding protein (BP)-1, IGFBP-2, IGFBP-3, insulin, and growth hormone. Int J Obes Relat Metab Disord. 1997 May;21(5):355-9. — View Citation

Norrish AE, Jackson RT, McRae CU. Non-steroidal anti-inflammatory drugs and prostate cancer progression. Int J Cancer. 1998 Aug 12;77(4):511-5. — View Citation

Norrish AE, Skeaff CM, Arribas GL, Sharpe SJ, Jackson RT. Prostate cancer risk and consumption of fish oils: a dietary biomarker-based case-control study. Br J Cancer. 1999 Dec;81(7):1238-42. — View Citation

Nyomba BL, Berard L, Murphy LJ. Free insulin-like growth factor I (IGF-I) in healthy subjects: relationship with IGF-binding proteins and insulin sensitivity. J Clin Endocrinol Metab. 1997 Jul;82(7):2177-81. — View Citation

Pandalai PK, Pilat MJ, Yamazaki K, Naik H, Pienta KJ. The effects of omega-3 and omega-6 fatty acids on in vitro prostate cancer growth. Anticancer Res. 1996 Mar-Apr;16(2):815-20. — View Citation

Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin. 1999 Jan-Feb;49(1):33-64, 1. — View Citation

Rose DP, Cohen LA. Effects of dietary menhaden oil and retinyl acetate on the growth of DU 145 human prostatic adenocarcinoma cells transplanted into athymic nude mice. Carcinogenesis. 1988 Apr;9(4):603-5. — View Citation

Rose DP, Connolly JM. Dietary fat, fatty acids and prostate cancer. Lipids. 1992 Oct;27(10):798-803. Review. — View Citation

Rose DP, Connolly JM. Effects of fatty acids and eicosanoid synthesis inhibitors on the growth of two human prostate cancer cell lines. Prostate. 1991;18(3):243-54. — View Citation

Rubenstein M, Shaw MW, McKiel CF, Ray PS, Guinan PD. Immunoregulatory markers in rats carrying Dunning R3327 H, G, or MAT-LyLu prostatic adenocarcinoma variants. Cancer Res. 1987 Jan 1;47(1):178-82. — View Citation

Scacchi M, Pincelli AI, Cavagnini F. Growth hormone in obesity. Int J Obes Relat Metab Disord. 1999 Mar;23(3):260-71. Review. — View Citation

Schuman LM, Mandel JS, Radke A, et al: Some elected features of the epidemiology of prostatic cancer: Minneapolis-St. Paul, Minnesota case-control study, 1976-1979. In: Magnus K, ed. Trends in cancer incidence. Washington DC: Hemisphere, 345-354, 1982.

Schuurman AG, van den Brandt PA, Dorant E, Brants HA, Goldbohm RA. Association of energy and fat intake with prostate carcinoma risk: results from The Netherlands Cohort Study. Cancer. 1999 Sep 15;86(6):1019-27. — View Citation

Severson RK, Nomura AM, Grove JS, Stemmermann GN. A prospective study of demographics, diet, and prostate cancer among men of Japanese ancestry in Hawaii. Cancer Res. 1989 Apr 1;49(7):1857-60. — View Citation

Shaw MW, Ablin RJ, Ray P, Rubenstein M, Guinan PD, McKiel CF. Immunobiology of the Dunning R-3327 rat prostate adenocarcinoma sublines: plasma and tumor effusion prostaglandins. Am J Reprod Immunol Microbiol. 1985 Jul;8(3):77-9. — View Citation

Shimizu 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. — View Citation

Shin BC, Ebner KE, Hudson BG, Carraway KL. Membrane glycoprotein differences between normal lactating mammary tissue and the R3230 AC mammary tumor. Cancer Res. 1975 May;35(5):1135-40. — View Citation

Signorello LB, Brismar K, Bergstrom R, Andersson SO, Wolk A, Trichopoulos D, Adami HO. Insulin-like growth factor-binding protein-1 and prostate cancer. J Natl Cancer Inst. 1999 Nov 17;91(22):1965-7. — View Citation

Smith BJ, Wills MR, Savory J. Prostaglandins and cancer. Ann Clin Lab Sci. 1983 Sep-Oct;13(5):359-65. Review. — View Citation

Stellman 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. — View Citation

Sugano M, Hirahara F. Polyunsaturated fatty acids in the food chain in Japan. Am J Clin Nutr. 2000 Jan;71(1 Suppl):189S-96S. doi: 10.1093/ajcn/71.1.189S. Review. — View Citation

Thissen JP, Ketelslegers JM, Underwood LE. Nutritional regulation of the insulin-like growth factors. Endocr Rev. 1994 Feb;15(1):80-101. Review. — View Citation

Tjandrawinata RR, Dahiya R, Hughes-Fulford M. Induction of cyclo-oxygenase-2 mRNA by prostaglandin E2 in human prostatic carcinoma cells. Br J Cancer. 1997;75(8):1111-8. — View Citation

Tsujii M, Kawano S, DuBois RN. Cyclooxygenase-2 expression in human colon cancer cells increases metastatic potential. Proc Natl Acad Sci U S A. 1997 Apr 1;94(7):3336-40. — View Citation

Vane JR, Bakhle YS, Botting RM. Cyclooxygenases 1 and 2. Annu Rev Pharmacol Toxicol. 1998;38:97-120. Review. — View Citation

Wang 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. — View Citation

West 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. — View Citation

Whittemore 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. — View Citation

Wolk A, Mantzoros CS, Andersson SO, Bergström R, Signorello LB, Lagiou P, Adami HO, Trichopoulos D. Insulin-like growth factor 1 and prostate cancer risk: a population-based, case-control study. J Natl Cancer Inst. 1998 Jun 17;90(12):911-5. — View Citation

Wynder 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. — View Citation

Yatani 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. Review. — View Citation

Yoshimura R, Sano H, Masuda C, Kawamura M, Tsubouchi Y, Chargui J, Yoshimura N, Hla T, Wada S. Expression of cyclooxygenase-2 in prostate carcinoma. Cancer. 2000 Aug 1;89(3):589-96. — View Citation

Yu H, Rohan T. Role of the insulin-like growth factor family in cancer development and progression. J Natl Cancer Inst. 2000 Sep 20;92(18):1472-89. Review. — View Citation

Zhou JR, Blackburn GL. Bridging animal and human studies: what are the missing segments in dietary fat and prostate cancer? Am J Clin Nutr. 1997 Dec;66(6 Suppl):1572S-1580S. doi: 10.1093/ajcn/66.6.1572S. Review. — View Citation

* Note: There are 70 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	check for insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer		4 weeks
Secondary	Check serum and tissue fatty acids as relevant intermediate biomarkers for prostate cancer		4 weeks