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| 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 |
| 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
|
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
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
| Principal Investigator: | Sally A. Shumaker, PhD | Wake Forest University |
More Information
| 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 |
|
breast cancer Tamoxifen Raloxifene hormone therapy |
|
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 |