CognitionPhase 3Co-STARNCT00687102
Cognition in the Study of Tamoxifen and Raloxifene
A Phase 3 study testing tamoxifen and raloxifene in people with Cognition and Aging, run by Wake Forest University at 134 sites in 2 countries.
Trial summary
The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- tamoxifen and raloxifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,498 participants
- Where
- 134 sitesin 2 countries
- Study dates
- Oct 2001to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Not enrolled in the STAR Trial
- Younger than 65 years of age
- Diagnosed with dementia
Trial locations and contacts
134 sites in 2 countries.
134 sites in 2 countries
United States127 sites
Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
Genesys Hurley Cancer Institute
Ann Arbor, Michigan, 48106
Genesys Regional Medical Center
Ann Arbor, Michigan, 48106
Oakwood Healthcare System
Ann Arbor, Michigan, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
St. John Hospital and Medical Center
Ann Arbor, Michigan, 48106
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237
Battle Creek Health Systems
Battle Creek, Michigan, 49016
Kaiser Permanente Ohio
Bedford, Ohio, 44146
Montana Cancer Consortium
Billings, Montana, 59101
Boston Medical Center
Boston, Massachusetts, 02118
Olympic Hematology and Oncology Associates
Bremerton, Washington, 98310
Roswell Park/Western New York STAR Consortium
Buffalo, New York, 14263
Naval Hospital Camp Pendleton
Camp Pendleton, California, 92055
Roper Hospital
Charleston, South Carolina, 29401
Presbyterian Hospital
Charlotte, North Carolina, 28204
Blumenthal Cancer Center
Charlotte, North Carolina, 28231
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
Ireland Cancer Center at Case Western Reserve University
Cleveland, Ohio, 44106
Penrose Cancer Center
Colorado Springs, Colorado, 80907
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Palmetto Richland Memorial Hospital
Columbia, South Carolina, 29203
CCOP Columbus
Columbus, Ohio, 43215
Bassett Healthcare
Cooperstown, New York, 13326
Methodist Hospitals of Dallas
Dallas, Texas, 75203
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Baylor-Sammons Cancer Center
Dallas, Texas, 75246
UT Southwestern Center for Breast Care
Dallas, Texas, 75390
Danville Hematology & Oncology, Inc.
Danville, Virginia, 24541
Genesis Medical Center
Davenport, Iowa, 52803
Colorado Cancer Research Program
Denver, Colorado, 80224
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010
Hematology Oncology Consultants
Duarte, California, 91010
Southern Nevada Cancer Research Foundation
Duarte, California, 91010
Finely Hospital, Wendt Regional Cancer Center
Dubuque, Iowa, 52001
St. Luke's Hospital
Duluth, Minnesota, 55802
Duluth Clinic
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27710
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28302
McLaren Regional Medical Center
Flint, Michigan, 48532
Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Baylor Medical Center at Garland
Garland, Texas, 75042
Gaston Memorial Hospital
Gastonia, North Carolina, 28054
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, 91204
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
Center for Cancer Care at Goshen Health Systems
Goshen, Indiana, 46526
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Great Falls Clinic, LLP
Great Falls, Montana, 59405
East Carolina University
Greenville, North Carolina, 27834
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Hartford Hospital
Hartford, Connecticut, 06102
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
University of Hawaii, Honolulu
Honolulu, Hawaii, 96813
Breast Care Center at Baylor College of Medicine/Methodist Hospital
Houston, Texas, 77030
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
St John's Regional Medical Center Cancer Center
Joplin, Missouri, 64804
Kalamazoo
Kalamazoo, Michigan, 49007
Good Samaritan Health Systems
Kearney, Nebraska, 68848
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Valley Tumor Medical Group
Lancaster, California, 93534
Michigan State University
Lansing, Michigan, 48910
Lima Memorial Hospital
Lima, Ohio, 45807
Cancer Resource Center
Lincoln, Nebraska, 68510
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79401
Southwest Cancer Center
Lubbock, Texas, 79415
Marquette General Hospital
Marquette, Michigan, 49855
Marshfield Clinic
Marshfield, Wisconsin, 54449
Hennepin Consortium
Minneapolis, Minnesota, 55415
Mercy Memorial Hospital Cancer Center
Monroe, Michigan, 48162
Community Hospital
Munster, Indiana, 46321
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Lawrence & Memorial Hospital
New London, Connecticut, 06320
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
Christiana Care Health Services
Newark, Delaware, 19718
Kaiser Permanente Division of Research
Oakland, California, 94612
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Methodist Cancer Center, Omaha
Omaha, Nebraska, 68114
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
CCOP Western Regional
Phoenix, Arizona, 85006
UPMC/UPCI/Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Berkshire Hematology Oncology, P.C.
Pittsfield, Massachusetts, 01201
Baylor Regional Medical Center
Plano, Texas, 75093
Columbia River Oncology Program
Portland, Oregon, 97225
Kaiser Permanente Center for Health Research (Oncology Research)
Portland, Oregon, 97227
Vassar Brothers Hospital
Poughkeepsie, New York, 12601
St. Mary-Corwin Medical Center
Pueblo, Colorado, 81004
Riverview Medical Center
Red Bank, New Jersey, 07701
North Valley Breast Clinic
Redding, California, 96001
University of Rochester Cancer Center
Rochester, New York, 14642
SwedishAmerican Hospital Regional Cancer Ctr
Rockford, Illinois, 61104
William Beaumont Hospital
Royal Oak, Michigan, 48073
Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Kaiser Permanente Oncology Research
San Diego, California, 92120
Naval Medical Center San Diego
San Diego, California, 92134
Cancer Foundation of Santa Barbara
Santa Barbara, California, 93105
Memorial Medical Center
Savannah, Georgia, 31403
Mercy Cancer Center, Scranton
Scranton, Pennsylvania, 18501
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
Swedish Medical Center
Seattle, Washington, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Sioux Valley Clinic Oncology
Sioux Falls, South Dakota, 57104
CCOP,Northern Indiana Research Consortium
South Bend, Indiana, 46601
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Cancer Research for the Ozarks
Springfield, Missouri, 65804
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
Missouri Baptist Medical Center
St Louis, Missouri, 63131
University Healthcare System
Syracuse, New York, 13202
H. Lee Moffitt Cancer Center and Research Center
Tampa, Florida, 33612
Scott and White Hospital
Temple, Texas, 76508
Fulton County Health Center
Toledo, Ohio, 43623
Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623
Arizona Cancer Center
Tucson, Arizona, 85719
Hematology & Oncology Associates Ltd
Tupelo, Mississippi, 38801
Carle Cancer Center
Urbana, Illinois, 61801
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
Via Christi Regional Medical Center
Wichita, Kansas, 67214
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, 27103
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Kaiser Permanente, Woodland Hills
Woodland Hills, California, 91367
Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
Yakima, Washington, 98902
York Cancer Center
York, Pennsylvania, 17403
Canada7 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N4N2
Women's Breast Health Centre
Ottawa, Ontario, K1Y4K7
Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials
Thunder Bay, Ontario, P7B6V4
North York General Hospital
Toronto, Ontario, M5S1B6
Women's College Hospital
Toronto, Ontario, M5S1B6
UBC-Vancouver Hospital & Health Science Center
Vancouver, British Columbia, V6K2B5
CancerCare Manitoba
Winnepeg, Manitoba, R3EOV9
About this study
Official title: Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene
The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.
Read the 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.
- Being tested
- tamoxifen, raloxifene
- Keywords
- breast cancer, Tamoxifen, Raloxifene, hormone therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifenDrug
Also called Nolvadex
oral tamoxifen plus placebo daily for 5 years
raloxifeneDrug
Also called Evista, Keoxifene
oral raloxifene plus placebo daily for 5 years
| Study group | Role | What they receive |
|---|---|---|
| Star participants assigned to Tamoxifen | Experimental | Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment. Receives: Drug: tamoxifen |
| Star participants assigned to Raloxifene | Experimental | Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment. Receives: Drug: raloxifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group
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.
Measured: Baseline and 3 Years
Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group
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.
Measured: Baseline and 3 Years
Secondary outcomes (6)
Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group
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.
Measured: Baseline and 3 Years
Mean Change From Baseline on Digit Span Test Scores by Treatment Group
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.
Measured: Baseline and 3 Years
Mean Change From Baseline on Card Rotations Test Scores by Treatment Group
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.
Measured: Baseline and 3 Years
Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group
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.
Measured: Baseline and 3 Years
Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group
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.
Measured: Baseline and 3 Years
Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group
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).
Measured: Baseline and 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startOct 2001
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sally A. Shumaker, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687102
- Sponsor's protocol ID
- IA0132
- Other IDs
- 1R13AG020218-01
- Acronym
- Co-STAR
- Status last verified
- Aug 2018
- First submitted
- 28 May 2008
- Last updated
- 12 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1176/appi.ajp.158.2.227.
PubMed 11156805Resnick 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. doi: 10.1212/wnl.49.6.1491.
PubMed 9409335Resnick 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. doi: 10.1006/hbeh.1998.1476.
PubMed 9799627
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene
- ClinicalTrials.gov ID
- NCT00687102
- Acronym / sponsor ID
- Co-STAR / IA0132
- Keywords
- breast cancer, Tamoxifen, Raloxifene, hormone therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,498 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2001
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Star participants assigned to Tamoxifen | Experimental | Drug: tamoxifenParticipants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment. |
| Star participants assigned to Raloxifene | Experimental | Drug: raloxifeneParticipants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Not enrolled in the STAR Trial
- Younger than 65 years of age
- Diagnosed with dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamoxifenAlso: Nolvadexoral tamoxifen plus placebo daily for 5 years | Drug | Star participants assigned to Tamoxifen |
| raloxifeneAlso: Evista, Keoxifeneoral raloxifene plus placebo daily for 5 years | Drug | Star participants assigned to Raloxifene |
Primary outcome
Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group
Time frame: 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
Time frame: 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.
6 secondary outcomes
Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group
Time frame: Baseline and 3 Years
Mean Change From Baseline on Digit Span Test Scores by Treatment Group
Time frame: Baseline and 3 Years
Mean Change From Baseline on Card Rotations Test Scores by Treatment Group
Time frame: Baseline and 3 Years
Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group
Time frame: Baseline and 3 Years
Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group
Time frame: Baseline and 3 Years
Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group
Time frame: Baseline and 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11156805Maki 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. doi: 10.1176/appi.ajp.158.2.227.
- Background: PubMed 9409335Resnick 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. doi: 10.1212/wnl.49.6.1491.
- Background: PubMed 9799627Resnick 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. doi: 10.1006/hbeh.1998.1476.
- Individual participant dataSharing planned: No
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Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sally A. Shumaker, PhD principal investigator
Wake Forest University Health Sciences
134 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tamoxifen and raloxifene in people with Cognition and Aging, run by Wake Forest University at 134 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 134 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group (time frame: Baseline and 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00687102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.