Cognition in the Study of Tamoxifen and Raloxifene

Condition(s) targeted: Cognition; Aging

Intervention: tamoxifen (Drug); raloxifene (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute on Aging (NIA)

Official(s) and/or principal investigator(s):
Sally A. Shumaker, PhD, Principal Investigator, Affiliation: Wake Forest University

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

Official title: Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene

Study design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome:

California Verbal Learning Test (CVLT)

Benton Visual Retention Test (BVRT) Form D

Secondary outcome:

Modified Mini-Mental State Exam

Prospective Memory Test

Primary Mental Abilities Vocabulary Test

Card Rotations Test

Finger Tapping Test

CVLT Long Delay Recall and Recognition Trials

Letter (F,A,S) and Semantic (fruits, vegetables) Fluency Tests

Digit Span

Positive and Negative Affect Scale (PANAS)

Geriatric Depression Scale (GDS)

Women's Health Initiative (WHI) Sleep Disturbance Measure Version 5

Menopausal Symptoms Checklist Version 5

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.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Female.

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

Tom Baker Cancer Centre, Calgary, Alberta T2N4N2, Canada

Arizona Cancer Center, Tucson, Arizona 85719, United States

CCOP Western Regional, Phoenix, Arizona 85006, United States

UBC-Vancouver Hospital & Health Science Center, Vancouver, British Columbia V6K2B5, Canada

City of Hope National Medical Center, Duarte, California 91010, United States

Cancer Foundation of Santa Barbara, Santa Barbara, California 93105, United States

Virginia K. Crosson Cancer Center, Fullerton, California 92835, United States

Hematology Oncology Consultants, Duarte, California 91010, United States

Valley Tumor Medical Group, Lancaster, California 93534, United States

North Valley Breast Clinic, Redding, California 96001, United States

Kaiser Permanente Oncology Research, San Diego, California 92120, United States

Kaiser Permanente, Woodland Hills, Woodland Hills, California 91367, United States

Glendale Memorial Hospital Comprehensive Cancer Center, Glendale, California 91204, United States

Naval Medical Center San Diego, San Diego, California 92134, United States

Naval Hospital Camp Pendleton, Camp Pendleton, California 92055, United States

Kaiser Permanente Division of Research, Oakland, California 94612, United States

Southern Nevada Cancer Research Foundation, Duarte, California 91010, United States

Ventura County Hematology-Oncology Specialists, Oxnard, California 93030, United States

Colorado Cancer Research Program, Denver, Colorado 80224, United States

Penrose Cancer Center, Colorado Springs, Colorado 80907, United States

St. Mary-Corwin Medical Center, Pueblo, Colorado 81004, United States

Hartford Hospital, Hartford, Connecticut 06102, United States

The Hospital of Central Connecticut, New Britain, Connecticut 06050, United States

Lawrence & Memorial Hospital, New London, Connecticut 06320, United States

Christiana Care Health Services, Newark, Delaware 19718, United States

Washington Cancer Institute, Washington, District of Columbia 20010, United States

H. Lee Moffitt Cancer Center and Research Center, Tampa, Florida 33612, United States

Lakeland Regional Cancer Center, Lakeland, Florida 33805, United States

Memorial Medical Center, Savannah, Georgia 31403, United States

University of Hawaii, Honolulu, Honolulu, Hawaii 96813, United States

Carle Cancer Center, Urbana, Illinois 61801, United States

SwedishAmerican Hospital Regional Cancer Ctr, Rockford, Illinois 61104, United States

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, United States

Center for Cancer Care at Goshen Health Systems, Goshen, Indiana 46526, United States

Community Hospital, Munster, Indiana 46321, United States

CCOP,Northern Indiana Research Consortium, South Bend, Indiana 46601, United States

Genesis Medical Center, Davenport, Iowa 52803, United States

Finely Hospital, Wendt Regional Cancer Center, Dubuque, Iowa 52001, United States

Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

Ochsner Cancer Institute, New Orleans, Louisiana 70121, United States

CancerCare Manitoba, Winnepeg, Manitoba R3EOV9, Canada

The Harry and Jeanette Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland 21237, United States

Boston Medical Center, Boston, Massachusetts 02118, United States

Berkshire Hematology Oncology, P.C., Pittsfield, Massachusetts 01201, United States

St. John Hospital and Medical Center, Ann Arbor, Michigan 48106, United States

Genesys Hurley Cancer Institute, Ann Arbor, Michigan 48106, United States

Genesys Regional Medical Center, Ann Arbor, Michigan 48106, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan 48106, United States

Oakwood Healthcare System, Ann Arbor, Michigan 48106, United States

William Beaumont Hospital, Royal Oak, Michigan 48073, United States

Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

Battle Creek Health Systems, Battle Creek, Michigan 49016, United States

Kalamazoo, Kalamazoo, Michigan 49007, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Michigan State University, Lansing, Michigan 48910, United States

Marquette General Hospital, Marquette, Michigan 49855, United States

McLaren Regional Medical Center, Flint, Michigan 48532, United States

Mercy Memorial Hospital Cancer Center, Monroe, Michigan 48162, United States

Duluth Clinic, Duluth, Minnesota 55805, United States

Hennepin Consortium, Minneapolis, Minnesota 55415, United States

St. Luke's Hospital, Duluth, Minnesota 55802, United States

Metro-Minnesota, St. Louis Park, Minnesota 55416, United States

Hematology & Oncology Associates Ltd, Tupelo, Mississippi 38801, United States

Ellis Fischel Cancer Center, Columbia, Missouri 65203, United States

Missouri Baptist Medical Center, St. Louis, Missouri 63131, United States

Cancer Research for the Ozarks, Springfield, Missouri 65804, United States

St John's Health System, Springfield, Missouri 65804, United States

St John's Regional Medical Center Cancer Center, Joplin, Missouri 64804, United States

Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med, St. Louis, Missouri 63110, United States

Montana Cancer Consortium, Billings, Montana 59101, United States

Great Falls Clinic, LLP, Great Falls, Montana 59405, United States

Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Cancer Resource Center, Lincoln, Nebraska 68510, United States

Good Samaritan Health Systems, Kearney, Nebraska 68848, United States

Methodist Cancer Center, Omaha, Omaha, Nebraska 68114, United States

Riverview Medical Center, Red Bank, New Jersey 07701, United States

Bassett Healthcare, Cooperstown, New York 13326, United States

Vassar Brothers Hospital, Poughkeepsie, New York 12601, United States

Roswell Park/Western New York STAR Consortium, Buffalo, New York 14263, United States

Hematology-Oncology Associates of CNY, East Syracuse, New York 13057, United States

University of Rochester Cancer Center, Rochester, New York 14642, United States

University Healthcare System, Syracuse, New York 13202, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

East Carolina University, Greenville, North Carolina 27834, United States

Presbyterian Hospital, Charlotte, North Carolina 28204, United States

Blumenthal Cancer Center, Charlotte, North Carolina 28231, United States

Southeastern Medical Oncology Center, Goldsboro, North Carolina 27534, United States

Gaston Memorial Hospital, Gastonia, North Carolina 28054, United States

Forsyth Regional Cancer Center, Winston-Salem, North Carolina 27103, United States

Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina 28791, United States

Cape Fear Valley Medical Center, Fayetteville, North Carolina 28302, United States

Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, United States

CCOP Columbus, Columbus, Ohio 43215, United States

Ireland Cancer Center at Case Western Reserve University, Cleveland, Ohio 44106, United States

Kaiser Permanente Ohio, Bedford, Ohio 44146, United States

Toledo Community Hospital Oncology Program, Toledo, Ohio 43623, United States

Fulton County Health Center, Toledo, Ohio 43623, United States

Lima Memorial Hospital, Lima, Ohio 45807, United States

Women's Breast Health Centre, Ottawa, Ontario K1Y4K7, Canada

Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials, Thunder Bay, Ontario P7B6V4, Canada

Women's College Hospital, Toronto, Ontario M5S1B6, Canada

North York General Hospital, Toronto, Ontario M5S1B6, Canada

Columbia River Oncology Program, Portland, Oregon 97225, United States

Kaiser Permanente Center for Health Research (Oncology Research), Portland, Oregon 97227, United States

UPMC/UPCI/Magee Women's Hospital, Pittsburgh, Pennsylvania 15213, United States

Mercy Cancer Center, Scranton, Scranton, Pennsylvania 18501, United States

York Cancer Center, York, Pennsylvania 17403, United States

Cancer Centers of the Carolinas, Greenville, South Carolina 29605, United States

Roper Hospital, Charleston, South Carolina 29401, United States

Palmetto Richland Memorial Hospital, Columbia, South Carolina 29203, United States

Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Sioux Valley Clinic Oncology, Sioux Falls, South Dakota 57104, United States

Thompson Cancer Survival Center, Knoxville, Tennessee 37916, United States

Don and Sybil Harrington Cancer Center, Amarillo, Texas 79106, United States

Breast Care Center at Baylor College of Medicine/Methodist Hospital, Houston, Texas 77030, United States

Baylor-Sammons Cancer Center, Dallas, Texas 75246, United States

Presbyterian Hospital of Dallas, Dallas, Texas 75231, United States

Baylor Medical Center at Garland, Garland, Texas 75042, United States

Baylor Regional Medical Center, Plano, Texas 75093, United States

Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas 79401, United States

University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, United States

Scott and White Hospital, Temple, Texas 76508, United States

Southwest Cancer Center, Lubbock, Texas 79415, United States

UT Southwestern Center for Breast Care, Dallas, Texas 75390, United States

Methodist Hospitals of Dallas, Dallas, Texas 75203, United States

Wilford Hall Medical Center, Lackland AFB, Texas 78236, United States

Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah 84112, United States

Danville Hematology & Oncology, Inc., Danville, Virginia 24541, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States

Swedish Medical Center, Seattle, Washington 98104, United States

Olympic Hematology and Oncology Associates, Bremerton, Washington 98310, United States

Benaroya Research Institute at Virginia Mason, Seattle, Washington 98101, United States

Yakima Valley Memorial Hospital/North Star Lodge Cancer Center, Yakima, Washington 98902, United States

Marshfield Clinic, Marshfield, Wisconsin 54449, United States

Related publications:

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.

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.

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.

Starting date: October 2001
Ending date: March 2008
Last updated: May 29, 2008