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The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance


N/A
50 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance


OBJECTIVES:

Primary

- To determine if a telephone-based dietary intervention compared to no intervention will
decrease clinical progression in AS patients.

Secondary

- To compare the incidence of active treatment (surgery, irradiation, local ablation, or
androgen deprivation) in AS patients receiving dietary intervention compared to no
intervention.

- To compare prostate cancer-related anxiety in AS patients receiving dietary
intervention compared to no intervention.

- To compare health-related quality of life in AS patients receiving dietary intervention
compared to no intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years
vs > 70 years), race (African American vs other), and time of baseline prostate biopsy (0-12
months before registration vs > 12-24 months before registration). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive the MEAL program intervention with dietary education and
telephone counseling sessions for 24 months. Patients receive the "Participant
Notebook", which provides written material describing the counseling program. It also
outlines the dietary targets, offers supporting information on strategies to achieve
these targets, supplies referent tools to help patients accurately estimate servings of
target foods, and offers recipes and articles about diet and prostate cancer. The
counseling sessions are divided into 4 phases, with the first three phases completed in
7 months and the fourth phase continuing for 17 months. The first phase comprises 6
counseling calls focusing on education and the rapid development of self-efficacy, the
second phase comprises 4 calls over a 2-month period focusing on practical and
consistent implementation of the dietary pattern, the third phase comprises 4 calls
over a 4-month period helping patients habituate to the dietary pattern by providing
regular performance reviews, and the fourth phase comprises 8 calls over a 17-month
period and is a maintenance phase. Patients are encouraged to achieve 7 servings per
day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings
per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings
per day of fruit. Patients also receive 8 regularly scheduled newsletters over the
course of 24 months. The newsletters focus on study goals and progress and provide tips
on achieving and maintaining diet change. They also include information on diet and
cancer, the challenges of diet change, the advances in prostate cancer control, and new
recipes.

- Arm II: Patients receive standard United States Department of Agriculture dietary
guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over
the course of 24 months. The newsletters contain general information about diet and
healthy lifestyle.

Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24
months for biomarker and pharmacogenomic studies.

Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional
Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate
Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index
Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program)
at baseline and at 6, 12, 18, and 24 months.

After study entry, patients are followed up every 3 months for 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate
diagnosed within 24 months prior to presentation

- < 25% of biopsy tissue cores positive for cancer

- ≤ 50% of any one biopsy tissue core positive for cancer

- Clinical stage ≤ T2a

- Patients who have prostate cancer with distant metastases are not eligible

- For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason
score ≤ (3 + 4) = 7

- Serum PSA < 10 ng/mL

- Baseline PSA for determination of eligibility must be measured after
discontinuation of any 5-alpha reductase inhibitors

- Patients are offered registration to the correlative study CALGB-151105

PATIENT CHARACTERISTICS:

- Life expectancy of at least 3 years

- Patients must be able to read and comprehend English language text and be able to
understand spoken English over the phone

- Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma
skin cancer) in the previous 5 years are not eligible

- Successful completion of three 24-hour dietary recalls during the run-in period

PRIOR CONCURRENT THERAPY:

- Patients who have had prior treatment for prostate cancer by surgery, irradiation,
local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or
androgen-deprivation therapy are not eligible

- Patients who are currently taking vitamin supplements including lycopene and
beta-carotene are eligible

- Patients who are currently taking coumadin are not eligible

- Patients consuming ≥ 6 servings per day of fruits and vegetables (not including
juices), as measured by the run-in dietary recalls, are not eligible

- Patients receiving treatment with 5-alpha reductase inhibitors within 90 days prior
to preregistration are not eligible

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression defined by PSA doubling time (PSADT) < 3 years, PSA > 10 at any time, or Gleason sum on repeat biopsy ≥ 7 (for men < 70 years) or ≥ 4+3 = 7 (for men ≥ 70 year)

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

J. Kellogg Parsons, MD, MHS

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Institutional Review Board

Study ID:

CDR0000687958

NCT ID:

NCT01238172

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms
  • Disease Progression

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Virginia Mason Medical CenterSeattle, Washington  98111
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Somerset Medical CenterSomerville, New Jersey  08876
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Munson Medical CenterTraverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Veterans Affairs Medical Center - HinesHines, Illinois  60141
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Poudre Valley HospitalFort Collins, Colorado  80524
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Mecosta County Medical CenterBig Rapids, Michigan  49307
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Fairbanks Cancer Treatment Center at Fairbanks Memorial HospitalFairbanks, Alaska  99701
St. Francis HospitalFederal Way, Washington  98003
Cascade Cancer Center at Evergreen Hospital Medical CenterKirkland, Washington  98034-3013
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Middlesex Hospital Cancer CenterMiddletown, Connecticut  06457
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
McFarland Clinic, PCAmes, Iowa  50010
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Providence Centralia HospitalCentralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Rocky Mountain OncologyCasper, Wyoming  82609
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical CenterEnglewood, New Jersey  07631
Pardee Memorial HospitalHendersonville, North Carolina  28791
Regional Cancer Center at Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Kaiser Permanente Medical Center - BellflowerBellflower, California  90706
Resurrection Medical CenterChicago, Illinois  60631
La Grange Memorial HospitalLa Grange, Illinois  60525
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Cancer Center at Phoenixville HospitalPhoenixville, Pennsylvania  19460
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
York Hospital's Oncology Treatment CenterYork, Maine  03909
Mercy General Health PartnersMuskegon, Michigan  49443
Bay Area HospitalCoos Bay, Oregon  97420
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Cleveland Clinic Florida - WestonWeston, Florida  33331
High Point Regional HospitalHigh Point, North Carolina  27261
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
California Cancer Care, Incorporated - GreenbraeGreenbrae, California  94904
Foundation Medical PartnersNashua, New Hampshire  03060
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Castle Medical CenterKailua, Hawaii  96734
Kauai Medical ClinicLihue, Hawaii  96766
Hays Medical CenterHays, Kansas  67601
Hutchinson Hospital CorporationHutchinson, Kansas  67502
Saint Helena HospitalSaint Helena, California  94574
Pacific Medical CenterSeattle, Washington  98104
Overlake Cancer Center at Overlake Hospital Medical CenterBellevue, Washington  98004
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Bloomington Hospital Regional Cancer InstituteBloomington, Indiana  47403
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
St. Rose Ambulatory and Surgery CenterGreat Bend, Kansas  67530
Kansas City Cancer Centers - WestKansas City, Kansas  66112
Kansas City Cancer Center - Shawnee MissionShawnee Mission, Kansas  66204
Kansas City Cancer Centers - EastLee's Summit, Missouri  64064
Spectrum Health Reed City HospitalReed City, Michigan  49677
Providence Regional Cancer PartnershipEverett, Washington  98201
Adult and Pediatric Urology, PLLPSartell, Minnesota  56377
Mount Kisco Medical Group, PCMount Kisco, New York  10549
St. Joseph Regional Medical CenterLewiston, Idaho  83501
Walter Reed National Military Medical CenterBethesda, Maryland  20889
D.N. Greenwald CenterMukwonago, Wisconsin  53149
Idaho Urologic Institute, PAMeridian, Idaho  83642
Oncare Hawaii, Incorporated - Pali MomiAiea, Hawaii  96701
Benefis Sletten Cancer InstituteGreat Falls, Montana  59405
Seattle Cancer Care Alliance at EvergreenHealthKirkland, Washington  98034
Saint Clare's HospitalDenville, New Jersey  07834