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Cognition in the Study of Tam...

Cognition in the Study of Tamoxifen and Raloxifene

Last Updated: 2018-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2008-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cognition Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Star participants assigned to Tamoxifen

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

Group Type EXPERIMENTAL

tamoxifen

Intervention Type DRUG

oral tamoxifen plus placebo daily for 5 years

Star participants assigned to Raloxifene

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

Group Type EXPERIMENTAL

raloxifene

Intervention Type DRUG

oral raloxifene plus placebo daily for 5 years

Interventions

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tamoxifen

oral tamoxifen plus placebo daily for 5 years

Intervention Type DRUG

raloxifene

oral raloxifene plus placebo daily for 5 years

Intervention Type DRUG

Other Intervention Names

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Nolvadex Evista, Keoxifene

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sally A. Shumaker, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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CCOP Western Regional

Phoenix, Arizona, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Naval Hospital Camp Pendleton

Camp Pendleton, California, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

Hematology Oncology Consultants

Duarte, California, United States

Site Status

Southern Nevada Cancer Research Foundation

Duarte, California, United States

Site Status

Virginia K. Crosson Cancer Center

Fullerton, California, United States

Site Status

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, United States

Site Status

Valley Tumor Medical Group

Lancaster, California, United States

Site Status

Kaiser Permanente Division of Research

Oakland, California, United States

Site Status

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

Site Status

North Valley Breast Clinic

Redding, California, United States

Site Status

Kaiser Permanente Oncology Research

San Diego, California, United States

Site Status

Naval Medical Center San Diego

San Diego, California, United States

Site Status

Cancer Foundation of Santa Barbara

Santa Barbara, California, United States

Site Status

Kaiser Permanente, Woodland Hills

Woodland Hills, California, United States

Site Status

Penrose Cancer Center

Colorado Springs, Colorado, United States

Site Status

Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

St. Mary-Corwin Medical Center

Pueblo, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Lawrence & Memorial Hospital

New London, Connecticut, United States

Site Status

Christiana Care Health Services

Newark, Delaware, United States

Site Status

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Site Status

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Center

Tampa, Florida, United States

Site Status

Memorial Medical Center

Savannah, Georgia, United States

Site Status

University of Hawaii, Honolulu

Honolulu, Hawaii, United States

Site Status

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, United States

Site Status

SwedishAmerican Hospital Regional Cancer Ctr

Rockford, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Center for Cancer Care at Goshen Health Systems

Goshen, Indiana, United States

Site Status

Community Hospital

Munster, Indiana, United States

Site Status

CCOP,Northern Indiana Research Consortium

South Bend, Indiana, United States

Site Status

Genesis Medical Center

Davenport, Iowa, United States

Site Status

Finely Hospital, Wendt Regional Cancer Center

Dubuque, Iowa, United States

Site Status

Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Ochsner Cancer Institute

New Orleans, Louisiana, United States

Site Status

The Harry and Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status