Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene
65 Years
N/A
Female
Cognition, Aging
Trial Information
Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
California Verbal Learning Test (CVLT)
Outcome Time Frame:
Baseline and annually up to 4 years post treatment
Safety Issue:
No
Principal Investigator
Sally A. Shumaker, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wake Forest University
Authority:
United States: Federal Government
Study ID:
IA0132
NCT ID:
NCT00687102
Start Date:
October 2001
Completion Date:
March 2008
Related Keywords:
- Cognition
- Aging
- breast cancer
- Tamoxifen
- Raloxifene
- hormone therapy
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| University of Rochester Cancer Center | Rochester, New York 14642 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Marshfield Clinic | Marshfield, Wisconsin 54449 |
| Marquette General Hospital | Marquette, Michigan 49855 |
| Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| Vassar Brothers Hospital | Poughkeepsie, New York 12601 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Michigan State University | East Lansing, Michigan 48824 |
| William Beaumont Hospital | Royal Oak, Michigan 48073 |
| Riverview Medical Center | Red Bank, New Jersey 07701 |
| Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| St. John Hospital and Medical Center | Detroit, Michigan 48236 |
| Palmetto Richland Memorial Hospital | Columbia, South Carolina 29203 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| York Cancer Center | York, Pennsylvania 17403 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| Duluth Clinic | Duluth, Minnesota 55805 |
| City of Hope National Medical Center | Los Angeles, California 91010 |
| Cape Fear Valley Medical Center | Fayetteville, North Carolina 28302-2000 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Penrose Cancer Center | Colorado Springs, Colorado 80933 |
| Carle Cancer Center | Urbana, Illinois 61801 |
| Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Washington Cancer Institute | Washington, District of Columbia 20010 |
| Genesis Medical Center | Davenport, Iowa 52804 |
| Community Hospital | Munster, Indiana 46321 |
| St. Luke's Hospital | Duluth, Minnesota 55805-2193 |
| Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
| Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Ochsner Cancer Institute | New Orleans, Louisiana 70121 |
| Good Samaritan Health Systems | Kearney, Nebraska 68847 |
| Glendale Memorial Hospital Comprehensive Cancer Center | Glendale, California 91204 |
| Valley Tumor Medical Group | Lancaster, California 93534 |
| North Valley Breast Clinic | Redding, California 96001 |
| Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
| Presbyterian Hospital of Dallas | Dallas, Texas 75231 |
| Baylor Medical Center at Garland | Irving, Texas 75061 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Swedish Medical Center | Seattle, Washington 98122-4307 |
| Berkshire Hematology Oncology, P.C. | Pittsfield, Massachusetts 01201 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| University of Texas M. D. Anderson Cancer Center | Houston, Texas 77030 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Southwest Cancer Center | Lubbock, Texas 79415 |
| Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
| Cancer Resource Center | Lincoln, Nebraska 68510-4844 |
| Methodist Hospitals of Dallas | Dallas, Texas 75203 |
| Virginia K. Crosson Cancer Center | Fullerton, California 92835 |
| Ventura County Hematology-Oncology Specialists | Oxnard, California 93030 |
| Danville Hematology & Oncology, Inc. | Danville, Virginia 24541 |
| Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
| Colorado Cancer Research Program | Denver, Colorado 80224 |
| Sioux Valley Clinic Oncology | Sioux Falls, South Dakota 57104 |
| The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
| McLaren Regional Medical Center | Flint, Michigan 48532 |
| Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
| Gaston Memorial Hospital | Gastonia, North Carolina 28054 |
| Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
| Columbia River Oncology Program | Portland, Oregon 97225 |
| Great Falls Clinic, LLP | Great Falls, Montana 59405 |
| Forsyth Regional Cancer Center | Winston-Salem, North Carolina 27103 |
| Hematology-Oncology Associates of CNY | East Syracuse, New York 13057 |
| Christiana Care Health Services | Newark, Delaware 19713 |
| Scott and White Hospital | Temple, Texas 76508 |
| East Carolina University | Greenville, North Carolina 27858 |
| Roper Hospital | Charleston, South Carolina 29401 |
| Benaroya Research Institute at Virginia Mason | Seattle, Washington 98101 |
| Toledo Community Hospital Oncology Program | Toledo, Ohio 43617 |
| The Harry and Jeanette Weinberg Cancer Institute at Franklin Square | Baltimore, Maryland 21237 |
| Huntsman Cancer Institute at the University of Utah | Salt Lake City, Utah 84112 |
| CCOP Western Regional | Phoenix, Arizona 85006 |
| Naval Hospital Camp Pendleton | Camp Pendleton, California 92055 |
| Hematology Oncology Consultants | Duarte, California 91010 |
| Southern Nevada Cancer Research Foundation | Duarte, California 91010 |
| Kaiser Permanente Division of Research | Oakland, California 94612 |
| Naval Medical Center San Diego | San Diego, California 92134 |
| Kaiser Permanente Oncology Research | San Diego, California 92120 |
| Cancer Foundation of Santa Barbara | Santa Barbara, California 93105 |
| Kaiser Permanente, Woodland Hills | Woodland Hills, California 91367 |
| St. Mary-Corwin Medical Center | Pueblo, Colorado 81004 |
| Lawrence & Memorial Hospital | New London, Connecticut 06320 |
| H. Lee Moffitt Cancer Center and Research Center | Tampa, Florida 33612 |
| Memorial Medical Center | Savannah, Georgia 31403 |
| University of Hawaii, Honolulu | Honolulu, Hawaii 96813 |
| SwedishAmerican Hospital Regional Cancer Ctr | Rockford, Illinois 61104 |
| Center for Cancer Care at Goshen Health Systems | Goshen, Indiana 46526 |
| CCOP,Northern Indiana Research Consortium | South Bend, Indiana 46601 |
| Finely Hospital, Wendt Regional Cancer Center | Dubuque, Iowa 52001 |
| Oakwood Healthcare System | Ann Arbor, Michigan 48106 |
| Battle Creek Health Systems | Battle Creek, Michigan 49016 |
| Kalamazoo | Kalamazoo, Michigan 49007 |
| Mercy Memorial Hospital Cancer Center | Monroe, Michigan 48162 |
| Hennepin Consortium | Minneapolis, Minnesota 55415 |
| Metro-Minnesota | St. Louis Park, Minnesota 55416 |
| Hematology & Oncology Associates Ltd | Tupelo, Mississippi 38801 |
| St John's Regional Medical Center Cancer Center | Joplin, Missouri 64804 |
| St John's Health System | Springfield, Missouri 65804 |
| Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med | St. Louis, Missouri 63110 |
| Montana Cancer Consortium | Billings, Montana 59101 |
| Missouri Valley Cancer Consortium | Omaha, Nebraska 68106 |
| Methodist Cancer Center, Omaha | Omaha, Nebraska 68114 |
| Roswell Park/Western New York STAR Consortium | Buffalo, New York 14263 |
| Bassett Healthcare | Cooperstown, New York 13326 |
| University Healthcare System | Syracuse, New York 13202 |
| Kaiser Permanente Ohio | Bedford, Ohio 44146 |
| Ireland Cancer Center at Case Western Reserve University | Cleveland, Ohio 44106 |
| CCOP Columbus | Columbus, Ohio 43215 |
| Kaiser Permanente Center for Health Research (Oncology Research) | Portland, Oregon 97227 |
| UPMC/UPCI/Magee Women's Hospital | Pittsburgh, Pennsylvania 15213 |
| Mercy Cancer Center, Scranton | Scranton, Pennsylvania 18501 |
| Don and Sybil Harrington Cancer Center | Amarillo, Texas 79106 |
| Baylor-Sammons Cancer Center | Dallas, Texas 75246 |
| UT Southwestern Center for Breast Care | Dallas, Texas 75390 |
| Breast Care Center at Baylor College of Medicine/Methodist Hospital | Houston, Texas 77030 |
| Baylor Regional Medical Center | Plano, Texas 75093 |
| Olympic Hematology and Oncology Associates | Bremerton, Washington 98310 |
| Yakima Valley Memorial Hospital/North Star Lodge Cancer Center | Yakima, Washington 98902 |
