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Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR)
This study has been completed.
First Received: May 28, 2008   Last Updated: May 29, 2008   History of Changes
Sponsor: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00687102
  Purpose

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


Condition Intervention Phase
Cognition
Aging
Drug: tamoxifen
Drug: raloxifene
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • California Verbal Learning Test (CVLT) [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Benton Visual Retention Test (BVRT) Form D [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Mini-Mental State Exam [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Prospective Memory Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Primary Mental Abilities Vocabulary Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Card Rotations Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Finger Tapping Test [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • CVLT Long Delay Recall and Recognition Trials [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Letter (F,A,S) and Semantic (fruits, vegetables) Fluency Tests [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Digit Span [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale (GDS) [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Women's Health Initiative (WHI) Sleep Disturbance Measure Version 5 [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]
  • Menopausal Symptoms Checklist Version 5 [ Time Frame: Baseline and annually up to 4 years post treatment ] [ Designated as safety issue: No ]

Enrollment: 1498
Study Start Date: October 2001
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
tamoxifen
Drug: tamoxifen
oral tamoxifen plus placebo daily for 5 years
2: Experimental
raloxifene
Drug: raloxifene
oral raloxifene plus placebo daily for 5 years

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), 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687102

  Hide Study Locations
Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85719
CCOP Western Regional
Phoenix, Arizona, United States, 85006
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Cancer Foundation of Santa Barbara
Santa Barbara, California, United States, 93105
Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Hematology Oncology Consultants
Duarte, California, United States, 91010
Valley Tumor Medical Group
Lancaster, California, United States, 93534
North Valley Breast Clinic
Redding, California, United States, 96001
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Kaiser Permanente, Woodland Hills
Woodland Hills, California, United States, 91367
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Naval Medical Center San Diego
San Diego, California, United States, 92134
Naval Hospital Camp Pendleton
Camp Pendleton, California, United States, 92055
Kaiser Permanente Division of Research
Oakland, California, United States, 94612
Southern Nevada Cancer Research Foundation
Duarte, California, United States, 91010
Kaiser Permanente Oncology Research
San Diego, California, United States, 92120
United States, Colorado
Colorado Cancer Research Program
Denver, Colorado, United States, 80224
Penrose Cancer Center
Colorado Springs, Colorado, United States, 80907
St. Mary-Corwin Medical Center
Pueblo, Colorado, United States, 81004
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Lawrence & Memorial Hospital
New London, Connecticut, United States, 06320
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
H. Lee Moffitt Cancer Center and Research Center
Tampa, Florida, United States, 33612
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
United States, Georgia
Memorial Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
University of Hawaii, Honolulu
Honolulu, Hawaii, United States, 96813
United States, Illinois
Carle Cancer Center
Urbana, Illinois, United States, 61801
SwedishAmerican Hospital Regional Cancer Ctr
Rockford, Illinois, United States, 61104
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Center for Cancer Care at Goshen Health Systems
Goshen, Indiana, United States, 46526
Community Hospital
Munster, Indiana, United States, 46321
CCOP,Northern Indiana Research Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
Finely Hospital, Wendt Regional Cancer Center
Dubuque, Iowa, United States, 52001
United States, Kansas
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Maryland
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Berkshire Hematology Oncology, P.C.
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
St. John Hospital and Medical Center
Ann Arbor, Michigan, United States, 48106
Kalamazoo
Kalamazoo, Michigan, United States, 49007
Genesys Regional Medical Center
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Oakwood Healthcare System
Ann Arbor, Michigan, United States, 48106
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Battle Creek Health Systems
Battle Creek, Michigan, United States, 49016
Genesys Hurley Cancer Institute
Ann Arbor, Michigan, United States, 48106
Henry Ford Health System
Detroit, Michigan, United States, 48202
Michigan State University
Lansing, Michigan, United States, 48910
Marquette General Hospital
Marquette, Michigan, United States, 49855
McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Mercy Memorial Hospital Cancer Center
Monroe, Michigan, United States, 48162
United States, Minnesota
Metro-Minnesota
St. Louis Park, Minnesota, United States, 55416
Hennepin Consortium
Minneapolis, Minnesota, United States, 55415
St. Luke's Hospital
Duluth, Minnesota, United States, 55802
Duluth Clinic
Duluth, Minnesota, United States, 55805
United States, Mississippi
Hematology & Oncology Associates Ltd
Tupelo, Mississippi, United States, 38801
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63131
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
St John's Health System
Springfield, Missouri, United States, 65804
St John's Regional Medical Center Cancer Center
Joplin, Missouri, United States, 64804
Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med
St. Louis, Missouri, United States, 63110
United States, Montana
Montana Cancer Consortium
Billings, Montana, United States, 59101
Great Falls Clinic, LLP
Great Falls, Montana, United States, 59405
United States, Nebraska
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Cancer Resource Center
Lincoln, Nebraska, United States, 68510
Good Samaritan Health Systems
Kearney, Nebraska, United States, 68848
Methodist Cancer Center, Omaha
Omaha, Nebraska, United States, 68114
United States, New Jersey
Riverview Medical Center
Red Bank, New Jersey, United States, 07701
United States, New York
Bassett Healthcare
Cooperstown, New York, United States, 13326
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12601
Roswell Park/Western New York STAR Consortium
Buffalo, New York, United States, 14263
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States, 13057
University of Rochester Cancer Center
Rochester, New York, United States, 14642
University Healthcare System
Syracuse, New York, United States, 13202
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28231
East Carolina University
Greenville, North Carolina, United States, 27834
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, United States, 27103
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States, 28302
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623
Ireland Cancer Center at Case Western Reserve University
Cleveland, Ohio, United States, 44106
Kaiser Permanente Ohio
Bedford, Ohio, United States, 44146
CCOP Columbus
Columbus, Ohio, United States, 43215
Fulton County Health Center
Toledo, Ohio, United States, 43623
Lima Memorial Hospital
Lima, Ohio, United States, 45807
United States, Oregon
Columbia River Oncology Program
Portland, Oregon, United States, 97225
Kaiser Permanente Center for Health Research (Oncology Research)
Portland, Oregon, United States, 97227
United States, Pennsylvania
UPMC/UPCI/Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Mercy Cancer Center, Scranton
Scranton, Pennsylvania, United States, 18501
York Cancer Center
York, Pennsylvania, United States, 17403
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
Roper Hospital
Charleston, South Carolina, United States, 29401
Palmetto Richland Memorial Hospital
Columbia, South Carolina, United States, 29203
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sioux Valley Clinic Oncology
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
Breast Care Center at Baylor College of Medicine/Methodist Hospital
Houston, Texas, United States, 77030
Baylor-Sammons Cancer Center
Dallas, Texas, United States, 75246
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Methodist Hospitals of Dallas
Dallas, Texas, United States, 75203
Baylor Regional Medical Center
Plano, Texas, United States, 75093
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79401
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Scott and White Hospital
Temple, Texas, United States, 76508
Southwest Cancer Center
Lubbock, Texas, United States, 79415
UT Southwestern Center for Breast Care
Dallas, Texas, United States, 75390
Baylor Medical Center at Garland
Garland, Texas, United States, 75042
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Danville Hematology & Oncology, Inc.
Danville, Virginia, United States, 24541
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
Yakima, Washington, United States, 98902
Olympic Hematology and Oncology Associates
Bremerton, Washington, United States, 98310
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Swedish Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N4N2
Canada, British Columbia
UBC-Vancouver Hospital & Health Science Center
Vancouver, British Columbia, Canada, V6K2B5
Canada, Manitoba
CancerCare Manitoba
Winnepeg, Manitoba, Canada, R3EOV9
Canada, Ontario
North York General Hospital
Toronto, Ontario, Canada, M5S1B6
Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials
Thunder Bay, Ontario, Canada, P7B6V4
Women's College Hospital
Toronto, Ontario, Canada, M5S1B6
Women's Breast Health Centre
Ottawa, Ontario, Canada, K1Y4K7
Sponsors and Collaborators
Investigators
Principal Investigator: Sally A. Shumaker, PhD Wake Forest University
  More Information

Publications:
Responsible Party: Wake Forest University Health Sciences ( Sally A. Shumaker, Ph.D. )
Study ID Numbers: IA0132, N01-AG-1-2106
Study First Received: May 28, 2008
Last Updated: May 29, 2008
ClinicalTrials.gov Identifier: NCT00687102     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
breast cancer
Tamoxifen
Raloxifene
hormone therapy

Additional relevant MeSH terms:
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2009