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Sponsors and Collaborators: |
Baylor Breast Care Center National Institutes of Health (NIH) National Surgical Adjuvant Breast and Bowel Project (NSABP) |
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Information provided by: | Baylor Breast Care Center |
ClinicalTrials.gov Identifier: | NCT00571857 |
Cognitive outcomes in Co-STAR participants will be compared with those from participants in a parallel study of the effects of HT on cognitive outcomes, WHISCA. 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 within the context of an observational trial. 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.
Condition | Intervention |
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Breast Cancer |
Drug: tamoxifen or raloxifene |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Investigator), Historical Control, Parallel Assignment |
Official Title: | Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene |
Enrollment: | 1123 |
Study Start Date: | September 2001 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Participants will be evenly distributed across the two treatment groups - tamoxifen or raloxifene. The assessments shall be administered in the same manner in each of the evaluations, providing data on rate of change over the 5 years of the study.
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Drug: tamoxifen or raloxifene
tamoxifen raloxifene
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Insights into the neural underpinnings of HT effects were gained in neuroimaging studies among a subset of BLSA volunteers. HT users and nonusers showed different patterns of regional cerebral blood flow during verbal and figural memory tasks in brain regions subserving memory functions. Though suggestive, these observational studies may be limited by the "healthy user bias," the tendency for HT users to be healthier and better educated than nonusers. To address those limitations, investigators at the BLSA and Wake Forest University School of Medicine initiated the Women's Health Initiative Study of Cognitive Aging or 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. WHISCA is an ancillary study to the Women's Health Initiative Memory Study (WHIMS) and is the largest randomized trial of hormone therapy on cognitive outcomes. WHISCA will provide invaluable data on the effects of estrogen treatments on cognitive aging.
Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR), sponsored and conducted in collaboration with the National Institute on Aging (NIA), is in response to the unique opportunity afforded by the STAR Trial, sponsored by the NCI and coordinated by the National Surgical Adjuvant Breast and Bowel Project (NSABP). Co-STAR studies the effects of tamoxifen and raloxifene on cognitive aging in selected non-demented women. As an ancillary study to STAR, Co-STAR will focus on the acquisition of data on verbal and non-verbal memory, and will also assess other cognitive abilities and mood, in STAR participants randomized to either tamoxifen or raloxifene. The assessments involve a battery of cognitive tests that have been shown in previous observational studies in the BLSA to be reliable longitudinally and sensitive to the effects of age and hormone treatment. Co-STAR will contrast the relative effects of tamoxifen and raloxifene across this battery of tests, with measures of verbal and non-verbal memory defining its two primary outcome measures. Co-STAR data will provide unique information about the effects of SERMs on age- associated cognitive decline. The methods employed in Co-STAR will parallel those used in WHISCA to allow comparisons between the two treatment groups in Co-STAR (tamoxifen and raloxifene) and the three treatment groups in WHISCA (placebo, estrogen therapy [ET], and ET plus progesterone).
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All women who enroll in the STAR Trial at sites participating in Co-STAR are eligible for enrollment into Co-STAR if:
Exclusion Criteria:
United States, Texas | |
Lester and Sue Smith Breast Center | |
Houston, Texas, United States, 77130 |
Principal Investigator: | Powel Brown, MD | Baylor College of Medicine |
Responsible Party: | Lester and Sue Smith Breast Center (Baylor College of Medicine) ( Powel Brown ) |
Study ID Numbers: | Cognitive Aging - STAR, CoStar |
Study First Received: | December 11, 2007 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00571857 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Hormone Therapy Aging Cognition |
Raloxifene Skin Diseases Breast Neoplasms Tamoxifen Breast Diseases |
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 Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |