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Brief Title: 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 ID: NCT00687102
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.
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
CCOP Western Regional, Phoenix, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
Naval Hospital Camp Pendleton, Camp Pendleton, California, United States
City of Hope National Medical Center, Duarte, California, United States
Hematology Oncology Consultants, Duarte, California, United States
Southern Nevada Cancer Research Foundation, Duarte, California, United States
Virginia K. Crosson Cancer Center, Fullerton, California, United States
Glendale Memorial Hospital Comprehensive Cancer Center, Glendale, California, United States
Valley Tumor Medical Group, Lancaster, California, United States
Kaiser Permanente Division of Research, Oakland, California, United States
Ventura County Hematology-Oncology Specialists, Oxnard, California, United States
North Valley Breast Clinic, Redding, California, United States
Kaiser Permanente Oncology Research, San Diego, California, United States
Naval Medical Center San Diego, San Diego, California, United States
Cancer Foundation of Santa Barbara, Santa Barbara, California, United States
Kaiser Permanente, Woodland Hills, Woodland Hills, California, United States
Penrose Cancer Center, Colorado Springs, Colorado, United States
Colorado Cancer Research Program, Denver, Colorado, United States
St. Mary-Corwin Medical Center, Pueblo, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Lawrence & Memorial Hospital, New London, Connecticut, United States
Christiana Care Health Services, Newark, Delaware, United States
Washington Cancer Institute, Washington, District of Columbia, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
H. Lee Moffitt Cancer Center and Research Center, Tampa, Florida, United States
Memorial Medical Center, Savannah, Georgia, United States
University of Hawaii, Honolulu, Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
SwedishAmerican Hospital Regional Cancer Ctr, Rockford, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Center for Cancer Care at Goshen Health Systems, Goshen, Indiana, United States
Community Hospital, Munster, Indiana, United States
CCOP,Northern Indiana Research Consortium, South Bend, Indiana, United States
Genesis Medical Center, Davenport, Iowa, United States
Finely Hospital, Wendt Regional Cancer Center, Dubuque, Iowa, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Ochsner Cancer Institute, New Orleans, Louisiana, United States
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Berkshire Hematology Oncology, P.C., Pittsfield, Massachusetts, United States
Genesys Hurley Cancer Institute, Ann Arbor, Michigan, United States
Genesys Regional Medical Center, Ann Arbor, Michigan, United States
Oakwood Healthcare System, Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
St. John Hospital and Medical Center, Ann Arbor, Michigan, United States
Battle Creek Health Systems, Battle Creek, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
McLaren Regional Medical Center, Flint, Michigan, United States
Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
Kalamazoo, Kalamazoo, Michigan, United States
Michigan State University, Lansing, Michigan, United States
Marquette General Hospital, Marquette, Michigan, United States
Mercy Memorial Hospital Cancer Center, Monroe, Michigan, United States
William Beaumont Hospital, Royal Oak, Michigan, United States
St. Luke's Hospital, Duluth, Minnesota, United States
Duluth Clinic, Duluth, Minnesota, United States
Hennepin Consortium, Minneapolis, Minnesota, United States
Metro-Minnesota, Saint Louis Park, Minnesota, United States
Hematology & Oncology Associates Ltd, Tupelo, Mississippi, United States
Ellis Fischel Cancer Center, Columbia, Missouri, United States
St John's Regional Medical Center Cancer Center, Joplin, Missouri, United States
Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Cancer Research for the Ozarks, Springfield, Missouri, United States
St John's Health System, Springfield, Missouri, United States
Montana Cancer Consortium, Billings, Montana, United States
Great Falls Clinic, LLP, Great Falls, Montana, United States
Good Samaritan Health Systems, Kearney, Nebraska, United States
Cancer Resource Center, Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Methodist Cancer Center, Omaha, Omaha, Nebraska, United States
Riverview Medical Center, Red Bank, New Jersey, United States
Roswell Park/Western New York STAR Consortium, Buffalo, New York, United States
Bassett Healthcare, Cooperstown, New York, United States
Hematology-Oncology Associates of CNY, East Syracuse, New York, United States
Vassar Brothers Hospital, Poughkeepsie, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
University Healthcare System, Syracuse, New York, United States
Presbyterian Hospital, Charlotte, North Carolina, United States
Blumenthal Cancer Center, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cape Fear Valley Medical Center, Fayetteville, North Carolina, United States
Gaston Memorial Hospital, Gastonia, North Carolina, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
East Carolina University, Greenville, North Carolina, United States
Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Forsyth Regional Cancer Center, Winston-Salem, North Carolina, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
Kaiser Permanente Ohio, Bedford, Ohio, United States
Ireland Cancer Center at Case Western Reserve University, Cleveland, Ohio, United States
CCOP Columbus, Columbus, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Fulton County Health Center, Toledo, Ohio, United States
Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
Columbia River Oncology Program, Portland, Oregon, United States
Kaiser Permanente Center for Health Research (Oncology Research), Portland, Oregon, United States
UPMC/UPCI/Magee Women's Hospital, Pittsburgh, Pennsylvania, United States
Mercy Cancer Center, Scranton, Scranton, Pennsylvania, United States
York Cancer Center, York, Pennsylvania, United States
Roper Hospital, Charleston, South Carolina, United States
Palmetto Richland Memorial Hospital, Columbia, South Carolina, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Sioux Valley Clinic Oncology, Sioux Falls, South Dakota, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Don and Sybil Harrington Cancer Center, Amarillo, Texas, United States
Methodist Hospitals of Dallas, Dallas, Texas, United States
Presbyterian Hospital of Dallas, Dallas, Texas, United States
Baylor-Sammons Cancer Center, Dallas, Texas, United States
UT Southwestern Center for Breast Care, Dallas, Texas, United States
Baylor Medical Center at Garland, Garland, Texas, United States
Breast Care Center at Baylor College of Medicine/Methodist Hospital, Houston, Texas, United States
University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Wilford Hall Medical Center, Lackland Air Force Base, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Southwest Cancer Center, Lubbock, Texas, United States
Baylor Regional Medical Center, Plano, Texas, United States
Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States
Danville Hematology & Oncology, Inc., Danville, Virginia, United States
Olympic Hematology and Oncology Associates, Bremerton, Washington, United States
Benaroya Research Institute at Virginia Mason, Seattle, Washington, United States
Swedish Medical Center, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge Cancer Center, Yakima, Washington, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
UBC-Vancouver Hospital & Health Science Center, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnepeg, Manitoba, Canada
Women's Breast Health Centre, Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials, Thunder Bay, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
Women's College Hospital, Toronto, Ontario, Canada
Name: Sally A. Shumaker, PhD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR