Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
NCT ID: NCT00681928
Last Updated: 2011-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
72 participants
OBSERVATIONAL
2007-10-31
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy volunteers.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Explore the impact of treatment with an aromatase inhibitor on the cognitive function of postmenopausal women with stage I-III breast cancer vs in cancer-free, age-matched healthy volunteers.
OUTLINE: Patients receive adjuvant anastrozole or letrozole in the absence of disease progression or unacceptable toxicity.
Patients and healthy volunteers undergo cognitive function testing consisting of neuropsychological battery tests and complete self-reported questionnaires (e.g., Squire Memory Self-Rating Questionnaire, and FACT-B Quality of Life Measure) regarding cognitive ability, quality of life, fatigue, and psychosocial status. Patients and healthy volunteers also undergo geriatric assessment at baseline and after 6 months of initiation with aromatase inhibitor therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breast Cancer patients receiving aromatase treatment
anastrozole
As determined by the subject's physician
letrozole
As determined by the subject's physician
questionnaire administration
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
cognitive assessment
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
psychosocial assessment and care
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
Healthy female controls age 60 and older
questionnaire administration
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
cognitive assessment
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
psychosocial assessment and care
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
anastrozole
As determined by the subject's physician
letrozole
As determined by the subject's physician
questionnaire administration
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
cognitive assessment
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
psychosocial assessment and care
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meets 1 of the following criteria:
* Patient diagnosed with breast cancer
* Stage I-III disease
* Estrogen receptor- and/or progesterone receptor-positive
* Planning to start treatment with anastrozole or letrozole
* Age-matched healthy volunteer (control)
* No history of breast cancer
* Not receiving adjuvant aromatase inhibitor therapy
PATIENT CHARACTERISTICS:
* Postmenopausal
* Able to converse, write, and read English
* No claustrophobia (patients participating in the PET scan correlative study)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior hormonal therapy, including estrogen replacement therapy
* No previous treatment with CNS radiation
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arti Hurria, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hurria A, Patel SK, Mortimer J, Luu T, Somlo G, Katheria V, Ramani R, Hansen K, Feng T, Chuang C, Geist CL, Silverman DH. The effect of aromatase inhibition on the cognitive function of older patients with breast cancer. Clin Breast Cancer. 2014 Apr;14(2):132-40. doi: 10.1016/j.clbc.2013.10.010. Epub 2013 Oct 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHNMC-07006
Identifier Type: -
Identifier Source: secondary_id
CDR0000589001
Identifier Type: REGISTRY
Identifier Source: secondary_id
07006
Identifier Type: -
Identifier Source: org_study_id