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Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT00687102
First received: May 28, 2008
Last updated: August 3, 2011
Last verified: May 2008
History of Changes
  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 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Wake Forest University:

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
Experimental: 1
tamoxifen
 Drug: tamoxifen
oral tamoxifen plus placebo daily for 5 years
Other Name: Nolvadex
Experimental: 2
raloxifene
 Drug: raloxifene
oral raloxifene plus placebo daily for 5 years
Other Name: Evista, Keoxifene

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
CCOP Western Regional
Phoenix, Arizona, United States, 85006
Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, California
Naval Hospital Camp Pendleton
Camp Pendleton, California, United States, 92055
Hematology Oncology Consultants
Duarte, California, United States, 91010
Southern Nevada Cancer Research Foundation
Duarte, California, United States, 91010
City of Hope National Medical Center
Duarte, California, United States, 91010
Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Valley Tumor Medical Group
Lancaster, California, United States, 93534
Kaiser Permanente Division of Research
Oakland, California, United States, 94612
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
North Valley Breast Clinic
Redding, California, United States, 96001
Naval Medical Center San Diego
San Diego, California, United States, 92134
Kaiser Permanente Oncology Research
San Diego, California, United States, 92120
Cancer Foundation of Santa Barbara
Santa Barbara, California, United States, 93105
Kaiser Permanente, Woodland Hills
Woodland Hills, California, United States, 91367
United States, Colorado
Penrose Cancer Center
Colorado Springs, Colorado, United States, 80907
Colorado Cancer Research Program
Denver, Colorado, United States, 80224
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
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
H. Lee Moffitt Cancer Center and Research Center
Tampa, Florida, United States, 33612
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
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
SwedishAmerican Hospital Regional Cancer Ctr
Rockford, Illinois, United States, 61104
Carle Cancer Center
Urbana, Illinois, United States, 61801
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
Genesys Hurley Cancer Institute
Ann Arbor, Michigan, United States, 48106
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
Battle Creek Health Systems
Battle Creek, Michigan, United States, 49016
Henry Ford Health System
Detroit, Michigan, United States, 48202
McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Kalamazoo
Kalamazoo, Michigan, United States, 49007
Michigan State University
Lansing, Michigan, United States, 48910
Marquette General Hospital
Marquette, Michigan, United States, 49855
Mercy Memorial Hospital Cancer Center
Monroe, Michigan, United States, 48162
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Duluth Clinic
Duluth, Minnesota, United States, 55805
St. Luke's Hospital
Duluth, Minnesota, United States, 55802
Hennepin Consortium
Minneapolis, Minnesota, United States, 55415
Metro-Minnesota
St. Louis Park, Minnesota, United States, 55416
United States, Mississippi
Hematology & Oncology Associates Ltd
Tupelo, Mississippi, United States, 38801
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
St John's Regional Medical Center Cancer Center
Joplin, Missouri, United States, 64804
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
St John's Health System
Springfield, Missouri, United States, 65804
Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med
St. Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63131
United States, Montana
Montana Cancer Consortium
Billings, Montana, United States, 59101
Great Falls Clinic, LLP
Great Falls, Montana, United States, 59405
United States, Nebraska
Good Samaritan Health Systems
Kearney, Nebraska, United States, 68848
Cancer Resource Center
Lincoln, Nebraska, United States, 68510
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
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
Roswell Park/Western New York STAR Consortium
Buffalo, New York, United States, 14263
Bassett Healthcare
Cooperstown, New York, United States, 13326
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States, 13057
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12601
University of Rochester Cancer Center
Rochester, New York, United States, 14642
University Healthcare System
Syracuse, New York, United States, 13202
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28231
Duke University Medical Center
Durham, North Carolina, United States, 27710
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States, 28302
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
East Carolina University
Greenville, North Carolina, United States, 27834
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Kaiser Permanente Ohio
Bedford, Ohio, United States, 44146
Ireland Cancer Center at Case Western Reserve University
Cleveland, Ohio, United States, 44106
CCOP Columbus
Columbus, Ohio, United States, 43215
Lima Memorial Hospital
Lima, Ohio, United States, 45807
Fulton County Health Center
Toledo, Ohio, United States, 43623
Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623
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
Roper Hospital
Charleston, South Carolina, United States, 29401
Palmetto Richland Memorial Hospital
Columbia, South Carolina, United States, 29203
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
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
Methodist Hospitals of Dallas
Dallas, Texas, United States, 75203
Baylor-Sammons Cancer Center
Dallas, Texas, United States, 75246
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
UT Southwestern Center for Breast Care
Dallas, Texas, United States, 75390
Baylor Medical Center at Garland
Garland, Texas, United States, 75042
Breast Care Center at Baylor College of Medicine/Methodist Hospital
Houston, Texas, United States, 77030
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Southwest Cancer Center
Lubbock, Texas, United States, 79415
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79401
Baylor Regional Medical Center
Plano, Texas, United States, 75093
Scott and White Hospital
Temple, Texas, United States, 76508
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
Olympic Hematology and Oncology Associates
Bremerton, Washington, United States, 98310
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Swedish Medical Center
Seattle, Washington, United States, 98104
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
Yakima, Washington, United States, 98902
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
Women's Breast Health Centre
Ottawa, Ontario, Canada, K1Y4K7
Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials
Thunder Bay, Ontario, Canada, P7B6V4
Women's College Hospital
Toronto, Ontario, Canada, M5S1B6
North York General Hospital
Toronto, Ontario, Canada, M5S1B6
Sponsors and Collaborators
Wake Forest University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sally A. Shumaker, PhD Wake Forest University
  More Information

Publications:

Responsible Party: Sally A. Shumaker, Ph.D., Wake Forest Health Sciences
ClinicalTrials.gov Identifier: NCT00687102     History of Changes
Obsolete Identifiers: NCT00571857
Other Study ID Numbers: IA0132, 1R13AG020218-01, N01-AG-1-2106
Study First Received: May 28, 2008
Last Updated: August 3, 2011
Health Authority: United States: Federal Government

Keywords provided by Wake Forest University:
breast cancer
Tamoxifen
Raloxifene
hormone therapy

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

ClinicalTrials.gov processed this record on May 22, 2013