A randomized trial of diet in men with early stage prostate cancer on active surveillance: Rationale and design of the Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance])

Contemporary Clinical Trials

Volumn 38, Issue 2, 2014, Pages 198-203

  Parsons, J Kellogg ^a,b,c   Pierce, John P ^d   Mohler, James ^e   Paskett, Electra ^f   Jung, Sin Ho ^g   Humphrey, Peter ^h   Taylor, John R ⁱ   Newman, Vicky A ^d   Barbier, Leslie ^d   Rock, Cheryl L ^d   Marshall, James ^e  

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b UNIVERSITY OF CALIFORNIA SAN DIEGO HEALTH SYSTEM   (United States)

^c VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e ROSWELL PARK CANCER INSTITUTE   (United States)

^f THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^g DUKE UNIVERSITY MEDICAL CENTER   (United States)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ UNIVERSITY OF CHICAGO   (United States)

Author keywords

Active surveillance; Carotenoids; Diet; Nutrition; Outcomes; Prostate cancer

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

AGED; CLINICAL TRIAL; CONTROLLED STUDY; COUNSELING; DIET THERAPY; DISEASE COURSE; HUMAN; MALE; METHODOLOGY; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; PROCEDURES; PROSTATIC NEOPLASMS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TELEPHONE; VEGETABLE; VERY ELDERLY;

AGED; AGED, 80 AND OVER; COUNSELING; DIET THERAPY; DISEASE PROGRESSION; HUMANS; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; QUALITY OF LIFE; RESEARCH DESIGN; TELEPHONE; VEGETABLES;

EID: 84901451904     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2014.05.002     Document Type: Article

References (35)

1. Welch H.G., Black W.C. Overdiagnosis in cancer. J Natl Cancer Inst 2010, 102(9):605-613.
2. Cooperberg M.R., Broering J.M., Kantoff P.W., Carroll P.R. Contemporary trends in low risk prostate cancer: risk assessment and treatment. J Urol 2007, 178(3 Pt 2):S14-S19.
3. Sanda M.G., Dunn R.L., Michalsk J., Sandler H.M., Northouse L., Hembroff L., et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008, 358(12):1250-1261.
4. Kopp R.P., Marshall L.M., Wang P.Y., Bauer D.C., Barrett-Connor E., Parsons J.K. The burden of urinary incontinence and urinary bother among elderly prostate cancer survivors. Eur Urol 2013, 64:672-679.
5. Wilt T.J., MacDonald R., Rutks I., Shamliyan T.A., Taylor B.C., Kane R.L. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008, 148(6):435-448.
6. Bul M., Zhu X., Valdagni R., Pickles T., Rannikko A., Biartell A., et al. Active surveillance for low-risk prostate cancer worldwide: the PRIAS study. Eur Urol 2013, 63(4):597-603.
7. Klotz L., Zhang L., Lam A., Nam R., Mamedov A., Loblaw A. Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol 2010, 28(1):126-131.
8. Tosoian J.J., Trock B.J., Landis P., Feng Z., Epstein J.I., Partin A.W., et al. Active surveillance program for prostate cancer: an update of the Johns Hopkins experience. J Clin Oncol 2011, 29(16):2185-2190.
9. Dall'Era M.A., Konety B.R., Cowan J.E., Shinohara K., Stauf F., Cooperberg M.R., et al. Active surveillance for the management of prostate cancer in a contemporary cohort. Cancer 2008, 112(12):2664-2670.
10. Sonn G.A., Aronson W., Litwin M.S. Impact of diet on prostate cancer: a review. Prostate Cancer Prostatic Dis 2005, 8(4):304-310.
11. Chan J.M., Gann P.H., Giovannucci E.L. Role of diet in prostate cancer development and progression. J Clin Oncol 2005, 23(32):8152-8160.
12. Nelson W.G., Demarzo A.M., Yegnasubramanian S. The diet as a cause of human prostate cancer. Cancer Treat Res 2014, 159:51-68.
13. Jian L., Du C.J., Lee A.H., Binns C.W. Do dietary lycopene and other carotenoids protect against prostate cancer?. Int J Cancer 2005, 113(6):1010-1014.
14. Barber N.J., Zhang X., Zhu G., Pramanik R., Barber J.A., Martin F.L., et al. Lycopene inhibits DNA synthesis in primary prostate epithelial cells in vitro and its administration is associated with a reduced prostate-specific antigen velocity in a phase II clinical study. Prostate Cancer Prostatic Dis 2006, 9(4):407-413.
15. Brooks J.D., Paton V.G., Vidanes G. Potent induction of phase 2 enzymes in human prostate cells by sulforaphane. Cancer Epidemiol Biomarkers Prev 2001, 10(9):949-954.
16. Singh A.V., Xiao D., Lew K.L., Dhir R., Singh S.V. Sulforaphane induces caspase-mediated apoptosis in cultured PC-3 human prostate cancer cells and retards growth of PC-3 xenografts in vivo. Carcinogenesis 2004, 25(1):83-90.
17. Spentzos D., Mantzoros C., Regan M.M., Morrissey M.E., Duggan S., Flickner-Garvey S., et al. Minimal effect of a low-fat/high soy diet for asymptomatic, hormonally naive prostate cancer patients. Clin Cancer Res 2003, 9(9):3282-3287.
18. Ornish D., Weidner G., Fair W.R., Marlin R., Pettengill E.B., Raisin C.J., et al. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol 2005, 174(3):1065-1069. [discussion 1069-1070].
19. Saxe G.A., Major J.M., Nguyen J.Y., Freeman K.M., Downs T.M., Salem C.E. Potential attenuation of disease progression in recurrent prostate cancer with plant-based diet and stress reduction. Integr Cancer Ther 2006, 5(3):206-213.
20. Frattaroli J., Weidner G., Dnistrian A.M., Kemp C., Daubenmier J.J, Marlin R.O., et al. Clinical events in prostate cancer lifestyle trial: results from two years of follow-up. Urology 2008, 72(6):1319-1323.
21. Ornish D., Magbanua M.J., Weidner G., Weinberg V., Kemp C., Green C., et al. Changes in prostate gene expression in men undergoing an intensive nutrition and lifestyle intervention. PNAS, USA 2008, 105(24):8369-8374.
22. Ornish D., Lin J., Daubenmier J., Weidner G., Epel E., Kemp C C., et al. Increased telomerase activity and comprehensive lifestyle changes: a pilot study. Lancet Oncol 2008, 9(11):1048-1057.
23. Ornish D., Lin J., Chan J.M., Epel E., Kemp C., Weidner G., et al. Effect of comprehensive lifestyle changes on telomerase activity and telomere length in men with biopsy-proven low-risk prostate cancer: 5-year follow-up of a descriptive pilot study. Lancet Oncol 2013, 14(11):1112-1120.
24. Parsons J.K., Newman V., Mohler J.L., Pierce J.P., Paskett E., Marshall J. The Men's Eating and Living (MEAL) study: a cancer and leukemia group B pilot trial of dietary intervention for the treatment of prostate cancer. Urology 2008, 72(3):633-637.
25. Parsons J.K., Newman V.A., Mohler J.L., Pierce J.P., Flatt S., Marshall J. Dietary modification in patients with prostate cancer on active surveillance: a randomized, multicentre feasibility study. BJU Int 2008, 101:1227-1231.
26. Pierce J.P., Newman V.A., Flatt S.W., Faerber S., Rock C.L, Natarajan L., et al. Telephone counseling intervention increases intakes of micronutrient- and phytochemical-rich vegetables, fruit and fiber in breast cancer survivors. J Nutr 2004, 134(2):452-458.
27. Miller W.R., Rollnick S. Motivational interviewing: preparing people for change 2002, Guilford Press, New York.
28. Liang K.Y., Zeger S.L. Longitudinal data analysis using generalized linear models. Biometrika 1986, 73:13-22.
29. Bang H., Jung S.H., George S.L. Sample size calculation for simulation-based multiple-testing procedures. J Biopharm Stat 2005, 15(6):957-967.
30. Pierce J.P., Natarajan L., Caan B.J., Parker B.A., Greenberg E.R., Flatt S.W., et al. Influence of a diet very high in vegetables, fruit, and fiber and low in fat on prognosis following treatment for breast cancer: the Women's Healthy Eating and Living (WHEL) randomized trial. JAMA 2007, 298(3):289-298.
31. Choices, values, and frames 2000, Cambridge University Press and Russell Sage Foundation, New York. D. Kahneman, A. Tversky (Eds.).
32. Bandura A. Self-efficacy: the exercise of self-control 1997, W.H. Freeman and Company, New York, New York.
33. Pierce J.P., Newman V.A., Natarajan L., Flatt S.W., Al-Delaimy W.K, Caan B.J., et al. Telephone counseling helps maintain long-term adherence to a high-vegetable dietary pattern. J Nutr 2007, 137:2291-2296.
34. Korfage I.J., Essink-Bot M.L., Janssens A.C., Schroder F.H., de Koning H.J. Anxiety and depression after prostate cancer diagnosis and treatment: 5-year follow-up. Br J Cancer 2006, 94(8):1093-1098.
35. Klotz L. Active surveillance for prostate cancer: for whom?. J Clin Oncol 2005, 23(32):8165-8169.