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

	Lead Sponsor	Other Sponsors/Collaborators
THINGS YOU CAN DO:	ID	Second ID
go back to previous page share this clinical trial print this clinical trial	NCT01238172	CALGB-70807
	Cancer and Leukemia Group B	National Cancer Institute (NCI)

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

Treatment Plan
Arm/Group Label	Arm/Group Type	Arm/Group Description
Arm I	Experimental	Patient receive the MEAL program intervention with dietary education and telephone counseling sessions of 24 months; the "Participant Notebook", which provides written material describing the counseling program, dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and recipes and articles about diet and prostate cancer. 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 and include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.
Arm II	Active Comparator	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.

Intervention(s)
counseling intervention, educational intervention, telephone-based intervention, therapeutic dietary intervention,

Patient eligibility
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 For detailed patient eligibility criteria for this clinical trial, please click here to show/hide

Patient eligibility


        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

For detailed patient eligibility criteria for this clinical trial, please click here to show/hide

Participating Study Sites

Name	City	State	Zip Code	Contact	Phone
Roswell Park Cancer Institute	Buffalo	NY	14263	Clinical Trials Office - Roswell Park Cancer Institute	877-275-7724
Cape Cod Hospital	Hyannis	MA	02601	Kelly M. Swanson	508-771-1800
Fletcher Allen Health Care - University Health Center Campus	Burlington	VT	05401	Clinical Trials Office - Fletcher Allen Health Care	802-656-8990
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	CT	06105	Philip J. Stella, MD	734-712-1000
Middlesex Hospital Cancer Center	Middletown	CT	06457	Susanna Hong	860-358-2050
Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	NJ	08043	Clinical Trials Office - Cancer Institute of New Jersey at Coo	856-325-6757
Somerset Medical Center	Somerville	NJ	08876	Clinical Trials Office - Somerset Medical Center	908-685-2481
CCOP - Christiana Care Health Services	Newark	DE	19713	Clinical Trial Office - CCOP - Christiana Care Health Services	302-623-4450
Tunnell Cancer Center at Beebe Medical Center	Lewes	DE	19958	Clinical Trials Office - Tunnell Cancer Center	302-645-3171
Union Hospital of Cecil County	Elkton MD	MD	21921	Stephen S. Grubbs, MD	302-366-1200
High Point Regional Hospital	High Point	NC	27261	Clinical Trials Office - High Point Regional Hospital	336-878-6107
Pardee Memorial Hospital	Hendersonville	NC	28791	James E. Radford, MD	828-692-8045
Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	FL	33805	Gameel B. Hodge, Jr.	863-603-6565
Mitchell Memorial Cancer Center at Owensboro Medical Health System	Owensboro	KY	42303	Kevin P. Ridenhour	270-688-3600
McDowell Cancer Center at Akron General Medical Center	Akron	OH	44307	Esther H. Rehmus, MD	330-344-6505
Mercy Regional Cancer Center at Mercy Hospital	Port Huron	MI	48060	Philip J. Stella, MD	734-712-1000
St. John Macomb Hospital	Warren	MI	48093	Philip J. Stella, MD	734-712-1000
CCOP - Michigan Cancer Research Consortium	Ann Arbor	MI	48106	Philip J. Stella, MD	734-712-1000
Saint Joseph Mercy Cancer Center	Ann Arbor	MI	48106	Philip J. Stella, MD	734-712-1000
Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	MI	48123	Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp	313-593-8090
St. Mary Mercy Hospital	Livonia	MI	48154	Philip J. Stella, MD	734-712-1000
Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	MI	48236	Clincial Trials Office - Van Elslander Cancer Center at St. Jo	313-343-3166
St. Joseph Mercy Oakland	Pontiac	MI	48341	Philip J. Stella, MD	734-712-1000
Hurley Medical Center	Flint	MI	48503	Clinical Trials Office - Hurley Medical Center	810-762-8057
Genesys Hurley Cancer Institute	Flint	MI	48503	Clinical Trials Office - Genesys Hurley Cancer Institute	810-762-8057
Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	MI	48601	Clinical Trials Office - Seton Cancer Institute - Saginaw	989-776-8411
Sparrow Regional Cancer Center	Lansing	MI	48912	Clinical Trials Office - Sparrow Regional Cancer Center	517-364-2890
Foote Memorial Hospital	Jackson	MI	49201	Philip J. Stella, MD	734-712-1000
McFarland Clinic, PC	Ames	IA	50010	Clinical Trials Office - McFarland Clinic, PC	515-239-2621
Siouxland Hematology-Oncology Associates, LLP	Sioux City	IA	51101	Donald B. Wender, MD, PhD	712-252-0088
Mercy Medical Center - Sioux City	Sioux City	IA	51104	Donald B. Wender, MD, PhD	712-252-0088
St. Luke's Regional Medical Center	Sioux City	IA	51104	Donald B. Wender, MD, PhD	712-252-0088
Holden Comprehensive Cancer Center at University of Iowa	Iowa City	IA	52242	Cancer Information Service	800-237-1225
Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	WI	53066	Clinical Trials Office - Regional Cancer Center at Oconomowoc	262-928-7878
Waukesha Memorial Hospital Regional Cancer Center	Waukesha	WI	53188	Clinical Trials Office - Waukesha Memorial Hospital Regional C	262-928-7632
Coborn Cancer Center	Saint Cloud	MN	56303	Donald J. Jurgens	320-229-4907
CentraCare Clinic - River Campus	Saint Cloud	MN	56303	Donald J. Jurgens	320-252-5131
Research Site	Alexandria	MN	56308	Donald J. Jurgens	Not Available
Adult and Pediatric Urology, PLLP	Sartell	MN	56377	Donald J. Jurgens	320-259-1411
Resurrection Medical Center	Chicago	IL	60631	James P Brown	773-792-5116
University of Chicago Cancer Research Center	Chicago	IL	60637	Clinical Trials Office - University of Chicago Cancer Research	773-834-7424
University Medical Center of Southern Nevada	Las Vegas	NV	89102	John A. Ellerton, MD, CM	702-384-0013
CCOP - Nevada Cancer Research Foundation	Las Vegas	NV	89106	John A. Ellerton, MD, CM	702-384-0013
Rebecca and John Moores UCSD Cancer Center	La Jolla	CA	92093	Clinical Trials Office - Rebecca and John Moores UCSD Cancer	858-822-5354
UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	CA	94115	Clinical Trials Office - UCSF Helen Diller Family Comprehensi	877-827-3222
Cancer Care Center at John Muir Health - Concord Campus	Concord	CA	94524	Clinical Trials Office - Cancer Care Center at John Muir Healt	925-674-2580
John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	CA	94598	Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Ca	925-941-4246
Mercy General Hospital	Sacramento	CA	95819	Colin P. Spears, MD	916-736-1536
Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	WA	98033	Jacqueline Vuky	425-899-3181
CCOP - Virginia Mason Research Center	Seattle	WA	98101	Jacqueline Vuky	206-341-0446
Virginia Mason Medical Center	Seattle	WA	98101	Jacqueline Vuky	206-223-6600
Pacific Medical Center	Seattle	WA	98104	Jacqueline Vuky	206-505-1101
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	AK	99701	Jacqueline Vuky	907-458-5380

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