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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00681928
First received: May 20, 2008
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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 Intervention
Breast Cancer
Drug: anastrozole
Drug: letrozole
Other: questionnaire administration
Procedure: cognitive assessment
Procedure: psychosocial assessment and care

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Impact of treatment with an aromatase inhibitor on cognitive function [ Time Frame: Prior to starting aromatase treatment and 6 months after starting the medication. ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer patients and healthy control subjects

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681928

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Arti Hurria, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided by City of Hope Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00681928     History of Changes
Other Study ID Numbers: 07006, P30CA033572, CHNMC-07006, CDR0000589001
Study First Received: May 20, 2008
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014