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

November 30, 2011 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients and healthy control subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer patients receiving aromatase treatment
Drug: anastrozole
As determined by the subject's physician
Drug: 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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of treatment with an aromatase inhibitor on cognitive function
Time Frame: Prior to starting aromatase treatment and 6 months after starting the medication.
Prior to starting aromatase treatment and 6 months after starting the medication.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (ESTIMATE)

May 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2011

Last Update Submitted That Met QC Criteria

November 30, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07006
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-07006
  • CDR0000589001 (REGISTRY: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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