Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy

Completed

• Conditions: Breast Cancer
• Interventions: Drug: anastrozole; Drug: letrozole; Other: questionnaire administration; Procedure: cognitive assessment; Procedure: psychosocial assessment and care

• Registration Number: NCT00681928
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-30
• Last Update Posted: 2011-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer patients receiving aromatase treatment	questionnaire administration	-
Breast Cancer patients receiving aromatase treatment	cognitive assessment	-
Breast Cancer patients receiving aromatase treatment	psychosocial assessment and care	-
Healthy female controls age 60 and older	questionnaire administration	-
Healthy female controls age 60 and older	cognitive assessment	-
Healthy female controls age 60 and older	psychosocial assessment and care	-
Breast Cancer patients receiving aromatase treatment	anastrozole	-
Breast Cancer patients receiving aromatase treatment	letrozole	-

Primary Outcome Measures

Name	Time	Method
Impact of treatment with an aromatase inhibitor on cognitive function	Prior to starting aromatase treatment and 6 months after starting the medication.

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States