Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
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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 |
- 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 |
Breast cancer patients and healthy control subjects
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| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Principal Investigator: | Arti Hurria, MD | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| 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 Letrozole Anastrozole |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 23, 2013