Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,498

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Oct 2001

Longer than P75 for phase_3

Geographic Reach

2 countries

134 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

Study Start

First participant enrolled

October 1, 2001

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed

9.7 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed

Last Updated

September 12, 2018

Status Verified

August 1, 2018

Enrollment Period

6.4 years

First QC Date

May 28, 2008

Results QC Date

August 4, 2017

Last Update Submit

August 13, 2018

Conditions

Cognition Aging

Keywords

breast cancerTamoxifenRaloxifenehormone therapy

Outcome Measures

Primary Outcomes (2)

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 Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper.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.
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.
Baseline and 3 Years

Secondary Outcomes (6)

Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group
Baseline and 3 Years
Mean Change From Baseline on Digit Span Test Scores by Treatment Group
Baseline and 3 Years
Mean Change From Baseline on Card Rotations Test Scores by Treatment Group
Baseline and 3 Years
Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group
Baseline and 3 Years
Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group
Baseline and 3 Years
+1 more secondary outcomes

Study Arms (2)

Star participants assigned to Tamoxifen

EXPERIMENTAL

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

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.

Drug: raloxifene

Interventions

tamoxifenDRUG

oral tamoxifen plus placebo daily for 5 years

Also known as: Nolvadex

Star participants assigned to Tamoxifen

raloxifeneDRUG

oral raloxifene plus placebo daily for 5 years

Also known as: Evista, Keoxifene

Star participants assigned to Raloxifene

Eligibility Criteria

Age65 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsOlder Adult (65+)

You may qualify if:

Women enrolled in STAR trial at a site participating in Co-STAR
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

You may not qualify if:

Not enrolled in the STAR Trial
Younger than 65 years of age
Diagnosed with dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Wake Forest Universitylead
National Institute on Aging (NIA)collaborator

Study Sites (134)

CCOP Western Regional

Phoenix, Arizona, 85006, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Naval Hospital Camp Pendleton

Camp Pendleton, California, 92055, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Hematology Oncology Consultants

Duarte, California, 91010, United States

Location

Southern Nevada Cancer Research Foundation

Duarte, California, 91010, United States

Location

Virginia K. Crosson Cancer Center

Fullerton, California, 92835, United States

Location

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, 91204, United States

Location

Valley Tumor Medical Group

Lancaster, California, 93534, United States

Location

Kaiser Permanente Division of Research

Oakland, California, 94612, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

North Valley Breast Clinic

Redding, California, 96001, United States

Location

Kaiser Permanente Oncology Research

San Diego, California, 92120, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Cancer Foundation of Santa Barbara

Santa Barbara, California, 93105, United States

Location

Kaiser Permanente, Woodland Hills

Woodland Hills, California, 91367, United States

Location

Penrose Cancer Center

Colorado Springs, Colorado, 80907, United States

Location

Colorado Cancer Research Program

Denver, Colorado, 80224, United States

Location

St. Mary-Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Lawrence & Memorial Hospital

New London, Connecticut, 06320, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

H. Lee Moffitt Cancer Center and Research Center

Tampa, Florida, 33612, United States

Location

Memorial Medical Center

Savannah, Georgia, 31403, United States

Location

University of Hawaii, Honolulu

Honolulu, Hawaii, 96813, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

SwedishAmerican Hospital Regional Cancer Ctr

Rockford, Illinois, 61104, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Center for Cancer Care at Goshen Health Systems

Goshen, Indiana, 46526, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

CCOP,Northern Indiana Research Consortium

South Bend, Indiana, 46601, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Finely Hospital, Wendt Regional Cancer Center

Dubuque, Iowa, 52001, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Ochsner Cancer Institute

New Orleans, Louisiana, 70121, United States

Location

The Harry and Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Berkshire Hematology Oncology, P.C.

Pittsfield, Massachusetts, 01201, United States

Location

Genesys Hurley Cancer Institute