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Dietary trial in prostate cancer: Early experience and implications for clinical trial design.

Abstract

Much epidemiologic and case-controlled evidence suggests that diet may be a modifier of prostate cancer risk. However, the role of dietary modification in men known to have prostate cancer is a matter of some debate. To elucidate the effect of diet and comprehensive lifestyle changes on cancer risk, we are conducting a randomized, prospective clinical trial on men with clinically localized prostate cancer who have selected "watchful waiting" as primary therapy. Since its inception in April 1997, 93 men have been randomized to control (n = 47) or dietary and lifestyle intervention (n = 46). Patients in the intervention group are asked to eat a low-fat, soy-supplemented vegan diet and take part in stress management, psychosocial group support, and exercise programs. After 1 year, adherence to all four interventions was greater than 80%, and no deaths or adverse outcomes have occurred. To date, we have collected prostate-specific antigen and endorectal magnetic resonance imaging and spectroscopy data on 63 patients (34 control and 29 intervention). This study demonstrates that a randomized, prospective dietary trial for men with localized prostate cancer is safe and feasible. The methodologies used provide insights into practical aspects of diet design and compliance assessment that may be useful templates for future dietary trials.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Preventive Medicine Research Institute, Sausalito, California, USA.

    , , ,

    Source

    Urology 57:4 Suppl 1 2001 Apr pg 200-1

    MeSH

    Diet, Vegetarian
    Dietary Fats
    Exercise
    Humans
    Life Style
    Male
    Prospective Studies
    Prostatic Neoplasms
    Self-Help Groups
    Stress, Physiological

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    11295627

    Citation

    Ornish, D M., et al. "Dietary Trial in Prostate Cancer: Early Experience and Implications for Clinical Trial Design." Urology, vol. 57, no. 4 Suppl 1, 2001, pp. 200-1.
    Ornish DM, Lee KL, Fair WR, et al. Dietary trial in prostate cancer: Early experience and implications for clinical trial design. Urology. 2001;57(4 Suppl 1):200-1.
    Ornish, D. M., Lee, K. L., Fair, W. R., Pettengill, E. B., & Carroll, P. R. (2001). Dietary trial in prostate cancer: Early experience and implications for clinical trial design. Urology, 57(4 Suppl 1), pp. 200-1.
    Ornish DM, et al. Dietary Trial in Prostate Cancer: Early Experience and Implications for Clinical Trial Design. Urology. 2001;57(4 Suppl 1):200-1. PubMed PMID: 11295627.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Dietary trial in prostate cancer: Early experience and implications for clinical trial design. AU - Ornish,D M, AU - Lee,K L, AU - Fair,W R, AU - Pettengill,E B, AU - Carroll,P R, PY - 2001/4/11/pubmed PY - 2001/6/19/medline PY - 2001/4/11/entrez SP - 200 EP - 1 JF - Urology JO - Urology VL - 57 IS - 4 Suppl 1 N2 - Much epidemiologic and case-controlled evidence suggests that diet may be a modifier of prostate cancer risk. However, the role of dietary modification in men known to have prostate cancer is a matter of some debate. To elucidate the effect of diet and comprehensive lifestyle changes on cancer risk, we are conducting a randomized, prospective clinical trial on men with clinically localized prostate cancer who have selected "watchful waiting" as primary therapy. Since its inception in April 1997, 93 men have been randomized to control (n = 47) or dietary and lifestyle intervention (n = 46). Patients in the intervention group are asked to eat a low-fat, soy-supplemented vegan diet and take part in stress management, psychosocial group support, and exercise programs. After 1 year, adherence to all four interventions was greater than 80%, and no deaths or adverse outcomes have occurred. To date, we have collected prostate-specific antigen and endorectal magnetic resonance imaging and spectroscopy data on 63 patients (34 control and 29 intervention). This study demonstrates that a randomized, prospective dietary trial for men with localized prostate cancer is safe and feasible. The methodologies used provide insights into practical aspects of diet design and compliance assessment that may be useful templates for future dietary trials. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/11295627/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090429500009742 DB - PRIME DP - Unbound Medicine ER -