Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
|ClinicalTrials.gov Identifier: NCT00681928|
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : December 2, 2011
RATIONALE: Gathering information about cognitive function over time in postmenopausal women with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor therapy and plan the best treatment.
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: anastrozole Drug: letrozole Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Observational Model:||Case Control|
|Official Title:||The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer|
|Study Start Date :||October 2007|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
|Breast Cancer patients receiving aromatase treatment||
As determined by the subject's physicianDrug: letrozole
As determined by the subject's physicianOther: questionnaire administration
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.Procedure: cognitive assessment
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.Procedure: 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||
Other: questionnaire administration
- Impact of treatment with an aromatase inhibitor on cognitive function [ Time Frame: Prior to starting aromatase treatment and 6 months after starting the medication. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681928
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Arti Hurria, MD||City of Hope Comprehensive Cancer Center|