Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

NCT01238172 | Completed Phase 3 Results DMC

• 2 other identifiers: CALGB-70807CDR0000687958
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 180

Brief Summary

RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer. PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).

  Up to 2 years

Secondary Outcomes (3)

• Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed

  Up to 2 years

• Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24

  Up to 2 years

• Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall

  Up to 2 years

Study Arms (2)

Arm A - MEAL Program Intervention

EXPERIMENTAL

Patients will receive dietary education and telephone counseling sessions over 24 months.

Other: dietary education and counseling

Arm B - Prostate Cancer Foundation Booklet

EXPERIMENTAL

Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.

Other: prostate cancer foundation booklet

Interventions

dietary education and counseling OTHER

Arm A - MEAL Program Intervention

prostate cancer foundation booklet OTHER

Arm B - Prostate Cancer Foundation Booklet

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Preregistration Eligibility: 1. Histologic Documentation: * The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility. * However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study. * Eligible patients must meet all of the following criteria: * Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration * \< 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 * NOTE: If a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen. However, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study. If prostate cancer is not detected in the biopsy specimen, the patient is not eligible. 2. Prior Treatment: 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. 3. Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible. 4. Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone. 5. Life expectancy of at least 3 years 6. Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible. 7. Patients receiving treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) within 90 days prior to preregistration are not eligible. Treatment with these agents during the protocol intervention is not permitted. 8. Patients who are currently taking coumadin are not eligible. 9. Participants will be men aged 50 to 80 years. 10. For men ≤ 70 years, biopsy Gleason score ≤ 6; for men \> 70 years, biopsy Gleason score ≤ (3 + 4) = 7. 11. Required Initial Laboratory Values: * Serum PSA \< 10 ng/mL * NOTE: Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors. Registration Eligibility: 1. Successful completion of three 24-hour dietary recalls during the run-in period. 2. Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (180)

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Kaiser Permanente Medical Center - Bellflower

Bellflower, California, 90706, United States

Location

California Cancer Care, Incorporated - Greenbrae

Greenbrae, California, 94904, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Saint Helena Hospital

St. Helena, California, 94574, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80528, United States

Location

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Middlesex Hospital Cancer Center

Middletown, Connecticut, 06457, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

Cleveland Clinic Florida - Weston

Weston, Florida, 33331, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817-3169, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Castle Medical Center

Kailua, Hawaii, 96734, United States

Location

Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Oncare Hawaii, Incorporated - Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

St. Joseph Regional Medical Center

Lewiston, Idaho, 83501, United States

Location

Idaho Urologic Institute, PA

Meridian, Idaho, 83642, United States

Location

Resurrection Medical Center

Chicago, Illinois, 60631, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

La Grange Memorial Hospital

La Grange, Illinois, 60525, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Bloomington Hospital Regional Cancer Institute

Bloomington, Indiana, 47403, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, 46545-1470, United States

Location

Saint Joseph Regional Medical Center

Mishawaka, Indiana, 46545-1470, United States

Location

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, 46563, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, 46391, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

Wendt Regional Cancer Center at Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51102, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

St. Rose Ambulatory and Surgery Center

Great Bend, Kansas, 67530, United States

Location

Hays Medical Center

Hays, Kansas, 67601, United States

Location

Hutchinson Hospital Corporation

Hutchinson, Kansas, 67502, United States

Location

Kansas City Cancer Centers - West

Kansas City, Kansas, 66112, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, 66210, United States

Location

Mount Carmel Regional Cancer Center

Pittsburg, Kansas, 66762, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Kansas City Cancer Center - Shawnee Mission

Shawnee Mission, Kansas, 66204, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Medical Center of Louisiana - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Maine Medical Center - Bramhall Campus

Portland, Maine, 04102, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

York Hospital's Oncology Treatment Center

York Village, Maine, 03909, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Mercy General Health Partners

Muskegon, Michigan, 49444, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Spectrum Health Reed City Hospital

Reed City, Michigan, 49677, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

Adult and Pediatric Urology, PLLP

Sartell, Minnesota, 56377, United States

Location

Truman Medical Center - Hospital Hill

Kansas City, Missouri, 64108, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

Kansas City Cancer Centers - South

Kansas City, Missouri, 64131, United States

Location

Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States

Location

Kansas City Cancer Centers - East

Lee's Summit, Missouri, 64064, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59102, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Foundation Medical Partners

Nashua, New Hampshire, 03060, United States

Location

Saint Clare's Hospital

Denville, New Jersey, 07834, United States

Location

Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Monter Cancer Center of the North Shore-LIJ Health System

Lake Success, New York, 11042, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mount Kisco Medical Group, PC

Mount Kisco, New York, 10549-3417, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

High Point Regional Hospital

High Point, North Carolina, 27261, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

Cancer Center at Phoenixville Hospital

Phoenixville, Pennsylvania, 19460, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78209, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

University Hospital - San Antonio

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Auburn Regional Center for Cancer Care

Auburn, Washington, 98002, United States

Location

Overlake Cancer Center at Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

Providence Centralia Hospital

Centralia, Washington, 98531-9027, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

St. Francis Hospital

Federal Way, Washington, 98003, United States

Location

Cascade Cancer Center at Evergreen Hospital Medical Center

Kirkland, Washington, 98033, United States

Location

Seattle Cancer Care Alliance at EvergreenHealth

Kirkland, Washington, 98034, United States

Location

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, 98506-5166, United States

Location

Good Samaritan Cancer Center

Puyallup, Washington, 98372, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Pacific Medical Center

Seattle, Washington, 98104, United States

Location

Franciscan Cancer Center at St. Joseph Medical Center

Tacoma, Washington, 98405-3004, United States

Location

Allenmore Hospital

Tacoma, Washington, 98405, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

St. Clare Hospital

Tacoma, Washington, 98499, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

D.N. Greenwald Center

Mukwonago, Wisconsin, 53149, United States

Location

Regional Cancer Center at Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

Rocky Mountain Oncology

Casper, Wyoming, 82609, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

• Parsons JK, Zahrieh D, Mohler JL, Paskett E, Hansel DE, Kibel AS, Liu H, Seisler DK, Natarajan L, White M, Hahn O, Taylor J, Hartman SJ, Stroup SP, Van Veldhuizen P, Hall L, Small EJ, Morris MJ, Pierce JP, Marshall J. Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial. JAMA. 2020 Jan 14;323(2):140-148. doi: 10.1001/jama.2019.20207.

  PMID: 31935026 DERIVED

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Nutrition Assessment; Counseling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: J. Kellogg Parsons, M.D., MHS
• Organization: Moores Cancer Center

jkparsons@ucsd.edu

858-822-7874

Study Officials

• J. Kellogg Parsons, MD, MHS

  University of California, San Diego

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: January 1, 2011
• Primary Completion: November 18, 2017
• Study Completion: January 15, 2019
• Last Updated: March 21, 2023
• Results First Posted: March 12, 2019

Record last verified: 2023-03

Locations

US (180)