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

Breast Cancer Clinical Trial

Official title:

The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681928
• Other study ID #: 07006
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: May 20, 2008
• Last updated: November 30, 2011
• Start date: October 2007
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• anastrozole
As determined by the subject's physician
• letrozole
As determined by the subject's physician

Other:
• 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.
• psychosocial assessment and care
For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of treatment with an aromatase inhibitor on cognitive function		Prior to starting aromatase treatment and 6 months after starting the medication.	No