Cognition in the Study of Tamoxifen and Raloxifene
- Registration Number
- NCT00687102
- Lead Sponsor
- Wake Forest University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1498
- 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
- Not enrolled in the STAR Trial
- Younger than 65 years of age
- Diagnosed with dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Star participants assigned to Tamoxifen tamoxifen Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment. Star participants assigned to Raloxifene raloxifene Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group Baseline and 3 Years Mean Change From Baseline on the Benton Visual Retention (BVRT) Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
The BVRT measures short term visual memory and visuo-constructional abilities. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score on the BVRT is the total number of errors, 0-26 represents the total number of theoretically possible errors. Lower score denotes better outcomes.Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group Baseline and 3 Years Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
The experimenter reads a list of 16 nouns aloud, at one-second intervals, in fixed order, over 3 learning trials (list A) . After each trial, the subject is asked to recall as many words as they can in any order (i.e., free recall) given a score 0-16 each. Total range as the sum of the 3 learning trials: 0 - 48. Participants were asked to recall a second interference list (List B) with a score range of 0-16. Free recall of list A are tested immediately after list B (short-delay) Total range 0- 16 , and again after 20 minutes (long-delay) 0-16. Each part of the scale is reported separately as Total List A trials, Total List B trials, Short-delay free recall, and Long-delay free recall.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline on Card Rotations Test Scores by Treatment Group Baseline and 3 Years Mean Change From Baseline on the Card Rotations Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures the ability to mentally manipulate figures in two and three-dimensions. On each of 28 trials, participants view sample line drawings of a geometric figure and 8 alterations representing 2 or 3-dimensional rotations of the drawing. Participants are asked to identify alternatives that show the sample in 2-D but not in 3-D. Total range 0 - 160 and the number of incorrect/correct responses is measure. Higher number of correct answers is a better outcome.Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group Baseline and 3 Years Mean Change From Baseline on the the Finger Tapping Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures motor speed, coordination, attention, alertness, slowing of responses, and motor control. In this test of motor speed and dexterity participants are asked to depress a lever as many times as possible in each of 7, 10-second trials, first with the right hand and next with the left hand. The highest and lowest scores are dropped; the score is the average of the remaining five trials for each hand.Higher scores represent better outcomes.Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group Baseline and 3 Years Mean Change From Baseline on the Positive and Negative Affect Schedule (PANAS). Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures positive and negative affect. Mood is assessed with the PANAS, a list of ten pleasant mood states (e.g., interested, proud, inspired) and ten unpleasant mood states (e.g., irritable, guilty, jittery). Respondents are asked to rate on a 5-point scale (1 being "very slightly or not at all" and 5 being "extremely") the extent to which they have experienced each mood during a specific time frame. Ratings for each item can range from 0 to 4 with total scores for positive affect and negative affect subscales ranging from 0 to 40. For positive affect, higher scores denote higher levels of positive affect and for negative affect, lower scores denote lower levels of negative affect.Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group Baseline and 3 Years Mean Change From Baseline on the Geriatric Depression Scale. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures depression in older adults. Mood is also assessed with the 15-item short form of the GDS which measures non-somatic features of depressed mood. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is 0-15, with 0-4 denoting better outcomes and a score of 5 and above denoting worse outcomes (depression).Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group Baseline and 3 Years Mean Change From Baseline on the Letter Fluency Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures cognitive function. In this test, the participant names as many words as possible in 1 minute, beginning with each letter for letter fluency (F, A, and S) and category for semantic fluency (fruits and vegetables). To score the administrator, counts up the total number letters or words that the individual is able to produce. The score minimum would be 0 and the maximum would be the total of correct items named within 1 minute. Higher scores represent better outcomes.Mean Change From Baseline on Digit Span Test Scores by Treatment Group Baseline and 3 Years Mean Change From Baseline on the Digit Span Test - Digits Forward and Digits backward Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures reasoning, verbal ability, and memory. The participant is asked to provide immediate recall of a series of digits in forward and backward sequences. The individual's score is the total number of items correctly repeated forwards or backwards. Total range 0 - 14, higher results denotes a better outcome.
Trial Locations
- Locations (134)
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square
🇺🇸Baltimore, Maryland, United States
CCOP Columbus
🇺🇸Columbus, Ohio, United States
Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Women's College Hospital
🇨🇦Toronto, Ontario, Canada
Benaroya Research Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Kaiser Permanente Oncology Research
🇺🇸San Diego, California, United States
Naval Medical Center San Diego
🇺🇸San Diego, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Virginia K. Crosson Cancer Center
🇺🇸Fullerton, California, United States
Penrose Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Hematology Oncology Consultants
🇺🇸Duarte, California, United States
Kaiser Permanente Division of Research
🇺🇸Oakland, California, United States
Memorial Medical Center
🇺🇸Savannah, Georgia, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Valley Tumor Medical Group
🇺🇸Lancaster, California, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
St. Mary-Corwin Medical Center
🇺🇸Pueblo, Colorado, United States
Hematology & Oncology Associates Ltd
🇺🇸Tupelo, Mississippi, United States
Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Lawrence & Memorial Hospital
🇺🇸New London, Connecticut, United States
Presbyterian Hospital of Dallas
🇺🇸Dallas, Texas, United States
UT Southwestern Center for Breast Care
🇺🇸Dallas, Texas, United States
Mercy Memorial Hospital Cancer Center
🇺🇸Monroe, Michigan, United States
Baylor Medical Center at Garland
🇺🇸Garland, Texas, United States
St John's Regional Medical Center Cancer Center
🇺🇸Joplin, Missouri, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Great Falls Clinic, LLP
🇺🇸Great Falls, Montana, United States
Palmetto Richland Memorial Hospital
🇺🇸Columbia, South Carolina, United States
Don and Sybil Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Methodist Hospitals of Dallas
🇺🇸Dallas, Texas, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Mercy Cancer Center, Scranton
🇺🇸Scranton, Pennsylvania, United States
Baylor-Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
CancerCare Manitoba
🇨🇦Winnepeg, Manitoba, Canada
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Breast Care Center at Baylor College of Medicine/Methodist Hospital
🇺🇸Houston, Texas, United States
Southwest Cancer Center
🇺🇸Lubbock, Texas, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
North York General Hospital
🇨🇦Toronto, Ontario, Canada
Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials
🇨🇦Thunder Bay, Ontario, Canada
Women's Breast Health Centre
🇨🇦Ottawa, Ontario, Canada
Hennepin Consortium
🇺🇸Minneapolis, Minnesota, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Huntsman Cancer Institute at the University of Utah
🇺🇸Salt Lake City, Utah, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP Western Regional
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
H. Lee Moffitt Cancer Center and Research Center
🇺🇸Tampa, Florida, United States
Battle Creek Health Systems
🇺🇸Battle Creek, Michigan, United States
Olympic Hematology and Oncology Associates
🇺🇸Bremerton, Washington, United States
University of Texas M. D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Good Samaritan Health Systems
🇺🇸Kearney, Nebraska, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Naval Hospital Camp Pendleton
🇺🇸Camp Pendleton, California, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Southern Nevada Cancer Research Foundation
🇺🇸Duarte, California, United States
North Valley Breast Clinic
🇺🇸Redding, California, United States
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
Cancer Foundation of Santa Barbara
🇺🇸Santa Barbara, California, United States
Kaiser Permanente, Woodland Hills
🇺🇸Woodland Hills, California, United States
Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
SwedishAmerican Hospital Regional Cancer Ctr
🇺🇸Rockford, Illinois, United States
Center for Cancer Care at Goshen Health Systems
🇺🇸Goshen, 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
Berkshire Hematology Oncology, P.C.
🇺🇸Pittsfield, Massachusetts, United States
Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Michigan State University
🇺🇸Lansing, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med
🇺🇸Saint Louis, Missouri, United States
St John's Health System
🇺🇸Springfield, Missouri, United States
Cancer Resource Center
🇺🇸Lincoln, Nebraska, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Glendale Memorial Hospital Comprehensive Cancer Center
🇺🇸Glendale, California, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
McLaren Regional Medical Center
🇺🇸Flint, Michigan, United States
Roswell Park/Western New York STAR Consortium
🇺🇸Buffalo, New York, United States
St. Luke's Hospital
🇺🇸Duluth, Minnesota, United States
Methodist Cancer Center, Omaha
🇺🇸Omaha, Nebraska, United States
Vassar Brothers Hospital
🇺🇸Poughkeepsie, New York, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Hematology-Oncology Associates of CNY
🇺🇸East Syracuse, New York, United States
Bassett Healthcare
🇺🇸Cooperstown, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Cape Fear Valley Medical Center
🇺🇸Fayetteville, North Carolina, United States
Gaston Memorial Hospital
🇺🇸Gastonia, North Carolina, United States
Blumenthal Cancer Center
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, 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
Ireland Cancer Center at Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Kaiser Permanente Ohio
🇺🇸Bedford, Ohio, United States
Fulton County Health Center
🇺🇸Toledo, Ohio, United States
Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Kaiser Permanente Center for Health Research (Oncology Research)
🇺🇸Portland, Oregon, United States
UPMC/UPCI/Magee Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
York Cancer Center
🇺🇸York, Pennsylvania, United States
Sioux Valley Clinic Oncology
🇺🇸Sioux Falls, South Dakota, United States
Baylor Regional Medical Center
🇺🇸Plano, Texas, United States
Scott and White Hospital
🇺🇸Temple, Texas, United States
Danville Hematology & Oncology, Inc.
🇺🇸Danville, Virginia, United States
Swedish Medical 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
Genesys Hurley Cancer Institute
🇺🇸Ann Arbor, Michigan, United States
Genesys Regional Medical Center
🇺🇸Ann Arbor, Michigan, United States
St. John Hospital and Medical Center
🇺🇸Ann Arbor, Michigan, United States
Oakwood Healthcare System
🇺🇸Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Forsyth Regional Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
University Healthcare System
🇺🇸Syracuse, New York, United States
University of Hawaii, Honolulu
🇺🇸Honolulu, Hawaii, United States
Ochsner Cancer Institute
🇺🇸New Orleans, Louisiana, United States
Roper Hospital
🇺🇸Charleston, South Carolina, United States