Clinical trial NCT00687102: Cognition in the Study of Tamoxifen and Raloxifene
Official title: Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cognition
Aging
Keywords: breast cancer
Tamoxifen
Raloxifene
hormone therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-05-30
Enrollment: 1498
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.

Detailed description: Recent reports indicate that hormone therapy (HT) may have a protective effect on the aging brain. Although previous studies have examined the effects of HT on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (SERMs), on cognitive aging. The two most commonly prescribed SERMs are tamoxifen, for treatment and prevention of breast cancer, and raloxifene, for maintaining bone density. In the face of potential widespread use of SERMs in healthy women, information on the effects of these agents on memory and other cognitive functions is essential.

The principal goals of Co-STAR are to compare the effects of tamoxifen and raloxifene

* on age-associated declines in measures of verbal and nonverbal memory in women over age 65
* other cognitive abilities and mood
* with those resulting from more common forms of HT, specifically ET (conjugated equine estrogen) and ET plus progesterone

Co-STAR results will be compared to results from the Women's Health Initiative Study of Cognitive Aging (WHISCA), a study involving 6-year longitudinal assessment of cognitive outcomes in 2969 women randomly assigned to receive active treatment (Premarin or Premarin plus medroxyprogesterone acetate) or placebo. A comparison of the Co-STAR treatment groups with the group of WHISCA participants receiving placebo will provide insights into the effects of SERMs relative to no treatment. A comparison of the Co-STAR treatment groups with WHISCA treatment groups receiving ET or ET plus progesterone will provide insights into the effects of SERMs relative to common HT treatments.

Co-STAR participants will be recruited from The National Cancer Institute's (NCI) Study of Tamoxifen and Raloxifene (STAR) NCT00003906, a multi-center, 5-year, randomized clinical trial among 22,000 women at increased risk for breast cancer, to compare the effects of tamoxifen and raloxifene on risk for breast cancer.

Eligibility criteria: Inclusion Criteria:

* Women enrolled in STAR trial at a site participating in Co-STAR
* 65 years of age or older
* Have been randomized into STAR but have not started taking the study drug OR enrolled in STAR for a minimum of one year
* Have not been diagnosed with dementia
* Have signed a separate consent document for the Co-STAR Study
* Previous diagnoses of chronic neurologic disease (Parkinson's disease, stroke, epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction, drug addiction, and other neurologic or psychiatric conditions will be recorded but will not serve as exclusion factors for this study

Exclusion Criteria:

* Not enrolled in the STAR Trial
* Younger than 65 years of age
* Diagnosed with dementia

Primary outcomes:
measure: Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group
timeFrame: Baseline and 3 Years
measure: Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group
timeFrame: Baseline and 3 Years
Secondary outcomes:
measure: Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group
timeFrame: Baseline and 3 Years
measure: Mean Change From Baseline on Digit Span Test Scores by Treatment Group
timeFrame: Baseline and 3 Years
measure: Mean Change From Baseline on Card Rotations Test Scores by Treatment Group
timeFrame: Baseline and 3 Years
measure: Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group
timeFrame: Baseline and 3 Years
measure: Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group
timeFrame: Baseline and 3 Years
measure: Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group
timeFrame: Baseline and 3 Years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CCOP Western Regional
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Camp Pendleton
country: United States
facility: Naval Hospital Camp Pendleton
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Duarte
country: United States
facility: Hematology Oncology Consultants
state: California
city: Duarte
country: United States
facility: Southern Nevada Cancer Research Foundation
state: California
city: Fullerton
country: United States
facility: Virginia K. Crosson Cancer Center
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital Comprehensive Cancer Center
state: California
city: Lancaster
country: United States
facility: Valley Tumor Medical Group
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Redding
country: United States
facility: North Valley Breast Clinic
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Oncology Research
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Santa Barbara
country: United States
facility: Cancer Foundation of Santa Barbara
state: California
city: Woodland Hills
country: United States
facility: Kaiser Permanente, Woodland Hills
state: California
city: Colorado Springs
country: United States
facility: Penrose Cancer Center
state: Colorado
city: Denver
country: United States
facility: Colorado Cancer Research Program
state: Colorado
city: Pueblo
country: United States
facility: St. Mary-Corwin Medical Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: New London
country: United States
facility: Lawrence & Memorial Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Center
state: Florida
city: Savannah
country: United States
facility: Memorial Medical Center
state: Georgia
city: Honolulu
country: United States
facility: University of Hawaii, Honolulu
state: Hawaii
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Rockford
country: United States
facility: SwedishAmerican Hospital Regional Cancer Ctr
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen Health Systems
state: Indiana
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: South Bend
country: United States
facility: CCOP,Northern Indiana Research Consortium
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Dubuque
country: United States
facility: Finely Hospital, Wendt Regional Cancer Center
state: Iowa
city: Wichita
country: United States
facility: Via Christi Regional Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Cancer Institute
state: Louisiana
city: Baltimore
country: United States
facility: The Harry and Jeanette Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology, P.C.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Ann Arbor
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Ann Arbor
country: United States
facility: Oakwood Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Battle Creek
country: United States
facility: Battle Creek Health Systems
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: McLaren Regional Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Clinical Oncology Program
state: Michigan
city: Kalamazoo
country: United States
facility: Kalamazoo
state: Michigan
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Marquette
country: United States
facility: Marquette General Hospital
state: Michigan
city: Monroe
country: United States
facility: Mercy Memorial Hospital Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital
state: Minnesota
city: Duluth
country: United States
facility: Duluth Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin Consortium
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro-Minnesota
state: Minnesota
city: Tupelo
country: United States
facility: Hematology & Oncology Associates Ltd
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: Joplin
country: United States
facility: St John's Regional Medical Center Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks
state: Missouri
city: Springfield
country: United States
facility: St John's Health System
state: Missouri
city: Billings
country: United States
facility: Montana Cancer Consortium
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic, LLP
state: Montana
city: Kearney
country: United States
facility: Good Samaritan Health Systems
state: Nebraska
city: Lincoln
country: United States
facility: Cancer Resource Center
state: Nebraska
city: Omaha
country: United States
facility: Missouri Valley Cancer Consortium
state: Nebraska
city: Omaha
country: United States
facility: Methodist Cancer Center, Omaha
state: Nebraska
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park/Western New York STAR Consortium
state: New York
city: Cooperstown
country: United States
facility: Bassett Healthcare
state: New York
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of CNY
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Syracuse
country: United States
facility: University Healthcare System
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Blumenthal Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Cape Fear Valley Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Memorial Hospital
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Hendersonville
country: United States
facility: Margaret R Pardee Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Regional Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Bedford
country: United States
facility: Kaiser Permanente Ohio
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center at Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: CCOP Columbus
state: Ohio
city: Lima
country: United States
facility: Lima Memorial Hospital
state: Ohio
city: Toledo
country: United States
facility: Fulton County Health Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Community Hospital Oncology Program
state: Ohio
city: Portland
country: United States
facility: Columbia River Oncology Program
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research (Oncology Research)
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC/UPCI/Magee Women's Hospital
state: Pennsylvania
city: Scranton
country: United States
facility: Mercy Cancer Center, Scranton
state: Pennsylvania
city: York
country: United States
facility: York Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Richland Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sioux Valley Clinic Oncology
state: South Dakota
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Amarillo
country: United States
facility: Don and Sybil Harrington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Methodist Hospitals of Dallas
state: Texas
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor-Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Center for Breast Care
state: Texas
city: Garland
country: United States
facility: Baylor Medical Center at Garland
state: Texas
city: Houston
country: United States
facility: Breast Care Center at Baylor College of Medicine/Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas M. D. Anderson Cancer Center
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Lubbock
country: United States
facility: Southwest Cancer Center
state: Texas
city: Plano
country: United States
facility: Baylor Regional Medical Center
state: Texas
city: Temple
country: United States
facility: Scott and White Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
city: Danville
country: United States
facility: Danville Hematology & Oncology, Inc.
state: Virginia
city: Bremerton
country: United States
facility: Olympic Hematology and Oncology Associates
state: Washington
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: UBC-Vancouver Hospital & Health Science Center
state: British Columbia
city: Winnepeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Ottawa
country: Canada
facility: Women's Breast Health Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Wake Forest University Health Sciences
name: Sally A. Shumaker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maki PM, Zonderman AB, Resnick SM. Enhanced verbal memory in nondemented elderly women receiving hormone-replacement therapy. Am J Psychiatry. 2001 Feb;158(2):227-33. doi: 10.1176/appi.ajp.158.2.227.
citation: Resnick SM, Metter EJ, Zonderman AB. Estrogen replacement therapy and longitudinal decline in visual memory. A possible protective effect? Neurology. 1997 Dec;49(6):1491-7. doi: 10.1212/wnl.49.6.1491.
citation: Resnick SM, Maki PM, Golski S, Kraut MA, Zonderman AB. Effects of estrogen replacement therapy on PET cerebral blood flow and neuropsychological performance. Horm Behav. 1998 Oct;34(2):171-82. doi: 10.1006/hbeh.1998.1476.