J Kellogg Parsons1, John P Pierce2, James Mohler3, Electra Paskett4, Sin-Ho Jung5, Peter Humphrey6, John R Taylor7, Vicky A Newman2, Leslie Barbier2, Cheryl L Rock2, James Marshall8. 1. Division of Urologic Oncology, UC San Diego Moores Cancer Center, La Jolla, CA, United States; Department of Urology, UC San Diego Health System, La Jolla, CA, United States; VA San Diego Healthcare System, La Jolla, CA, United States. Electronic address: jkparsons@ucsd.edu. 2. Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, CA, United States. 3. Department of Urology, Roswell Park Cancer Institute, Buffalo, NY, United States. 4. Department of Medicine, College of Medicine, Comprehensive Cancer Center, Ohio State University, Columbus, OH, United States. 5. Alliance Statistics and Data Center, Duke University Medical Center, Durham, NC, United States. 6. Department of Pathology, Washington University Medical School, St. Louis, MO, United States. 7. Alliance Central Protocol Operations, University of Chicago, Chicago, IL, United States. 8. Department of Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, NY, United States.
Abstract
BACKGROUND:Diet may substantially alter prostate cancer initiation and progression. However, large-scale clinical trials of diet modification have yet to be performed for prostate cancer. The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) is investigating the effect of increased vegetable consumption on clinical progression in men with localized prostate cancer. STUDY DESIGN:MEAL is a randomized, phase III clinical trial designed to test whether an intervention that increases vegetable intake will decrease the incidence of clinical progression in men with clinically localized prostate cancer on active surveillance. We are randomizing 464 patients to either avalidated telephone-based diet counseling intervention or a control condition in which patients receive a published diet guideline. The intervention will continue for two years. The primary outcome variable is clinical progression defined by serum prostate-specific antigen (PSA) and pathological findings on follow-up prostate biopsy. Secondary outcome variables include incidence of surgical and non-surgical treatments for prostate cancer, prostate-cancer related patient anxiety and health-related quality of life. CONCLUSION: The MEAL Study is assessing the effectiveness of a high-vegetable diet intervention for preventing clinical progression in men with localized prostate cancer on active surveillance.
RCT Entities:
BACKGROUND: Diet may substantially alter prostate cancer initiation and progression. However, large-scale clinical trials of diet modification have yet to be performed for prostate cancer. The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) is investigating the effect of increased vegetable consumption on clinical progression in men with localized prostate cancer. STUDY DESIGN: MEAL is a randomized, phase III clinical trial designed to test whether an intervention that increases vegetable intake will decrease the incidence of clinical progression in men with clinically localized prostate cancer on active surveillance. We are randomizing 464 patients to either a validated telephone-based diet counseling intervention or a control condition in which patients receive a published diet guideline. The intervention will continue for two years. The primary outcome variable is clinical progression defined by serum prostate-specific antigen (PSA) and pathological findings on follow-up prostate biopsy. Secondary outcome variables include incidence of surgical and non-surgical treatments for prostate cancer, prostate-cancer related patientanxiety and health-related quality of life. CONCLUSION: The MEAL Study is assessing the effectiveness of a high-vegetable diet intervention for preventing clinical progression in men with localized prostate cancer on active surveillance.
Authors: Gordon A Saxe; Jacqueline M Major; Jacquelyn Y Nguyen; Karen M Freeman; Tracy M Downs; Carol E Salem Journal: Integr Cancer Ther Date: 2006-09 Impact factor: 3.279
Authors: N J Barber; X Zhang; G Zhu; R Pramanik; J A Barber; F L Martin; J D H Morris; G H Muir Journal: Prostate Cancer Prostatic Dis Date: 2006-09-19 Impact factor: 5.554
Authors: Martin G Sanda; Rodney L Dunn; Jeff Michalski; Howard M Sandler; Laurel Northouse; Larry Hembroff; Xihong Lin; Thomas K Greenfield; Mark S Litwin; Christopher S Saigal; Arul Mahadevan; Eric Klein; Adam Kibel; Louis L Pisters; Deborah Kuban; Irving Kaplan; David Wood; Jay Ciezki; Nikhil Shah; John T Wei Journal: N Engl J Med Date: 2008-03-20 Impact factor: 91.245
Authors: J Kellogg Parsons; Vicky A Newman; James L Mohler; John P Pierce; Shirley Flatt; James Marshall Journal: BJU Int Date: 2008-01-24 Impact factor: 5.588
Authors: John P Pierce; Vicky A Newman; Loki Natarajan; Shirley W Flatt; Wael K Al-Delaimy; Bette J Caan; Jennifer A Emond; Susan Faerber; Ellen B Gold; Richard A Hajek; Kathryn Hollenbach; Lovell A Jones; Njeri Karanja; Sheila Kealey; Lisa Madlensky; James Marshall; Cheryl Ritenbaugh; Cheryl L Rock; Marcia L Stefanick; Cynthia Thomson; Linda Wasserman; Barbara A Parker Journal: J Nutr Date: 2007-10 Impact factor: 4.798
Authors: John P Pierce; Loki Natarajan; Bette J Caan; Barbara A Parker; E Robert Greenberg; Shirley W Flatt; Cheryl L Rock; Sheila Kealey; Wael K Al-Delaimy; Wayne A Bardwell; Robert W Carlson; Jennifer A Emond; Susan Faerber; Ellen B Gold; Richard A Hajek; Kathryn Hollenbach; Lovell A Jones; Njeri Karanja; Lisa Madlensky; James Marshall; Vicky A Newman; Cheryl Ritenbaugh; Cynthia A Thomson; Linda Wasserman; Marcia L Stefanick Journal: JAMA Date: 2007-07-18 Impact factor: 56.272
Authors: Timothy J Wilt; Roderick MacDonald; Indulis Rutks; Tatyana A Shamliyan; Brent C Taylor; Robert L Kane Journal: Ann Intern Med Date: 2008-02-04 Impact factor: 25.391
Authors: J Kellogg Parsons; David Zahrieh; James L Mohler; Electra Paskett; Donna E Hansel; Adam S Kibel; Heshan Liu; Drew K Seisler; Loki Natarajan; Martha White; Olwen Hahn; John Taylor; Sheri J Hartman; Sean P Stroup; Peter Van Veldhuizen; Lannis Hall; Eric J Small; Michael J Morris; John P Pierce; James Marshall Journal: JAMA Date: 2020-01-14 Impact factor: 56.272
Authors: J Kellogg Parsons; John P Pierce; James Mohler; Electra Paskett; Sin-Ho Jung; Michael J Morris; Eric Small; Olwen Hahn; Peter Humphrey; John Taylor; James Marshall Journal: BJU Int Date: 2017-05-21 Impact factor: 5.588