Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
RATIONALE: Gathering information over time from laboratory tests, imaging scans, and assessment tests may help doctors learn more about the side effects of chemotherapy and plan the best treatment.
PURPOSE: This clinical trial is studying the effects of chemotherapy on the brain in women with newly diagnosed early-stage breast cancer.
Chemotherapeutic Agent Toxicity
Long-term Effects Secondary to Cancer Therapy in Adults
Psychosocial Effects of Cancer and Its Treatment
Drug: aromatase inhibition therapy
Drug: doxorubicin hydrochloride
Other: metabolic assessment
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: cognitive assessment
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effects of Chemotherapy on Brain Structure and Function|
- Change in glucose metabolism [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
- MRI measures of the brain (hippocampal volume, cortical gray matter volume, white matter signal hyperintensities, ventricular volume, whole brain volume) [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
- Measures of cognitive function over time by Wechsler memory scale, word list memory, Stroop Color Word Test, Boston Naming Test, verbal fluency, FACIT-B functional assessment, Mini Mental State Exam, Hamilton Depression Rating Scale (Ham-D), Beck De ... [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
- Cognitive assessments over time by FACIT-B, Ham-D, BDI-II, STAI, FSI, and MASQ, demographic and medical data [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
- To prospectively evaluate the acute (1 month after chemotherapy) and relatively long-term (18 months after chemotherapy) effects of standard-dose chemotherapy and/or hormonal therapy with aromatase inhibition on brain function using positron emission tomography (PET) and the glucose metabolism tracer fludeoxyglucose F 18 in women with newly diagnosed, early stage breast cancer.
- To evaluate the acute and relatively long-term effects of chemotherapy and/or hormonal therapy on MRI measurements of hippocampal volume, cortical grey matter volume, white matter signal hyperintensities, ventricular volume, and whole brain volume in these patients.
- To evaluate the acute and relatively long-term effects of chemotherapy and/or hormonal therapy with aromatase inhibition on cognitive function in these patients.
- To explore the characteristics of these patients that renders them more vulnerable to chemotherapy and/or estrogen suppression-induced cognitive decline.
OUTLINE: Patients are stratified according to planned adjuvant chemotherapy (chemotherapy and hormonal therapy vs hormonal therapy vs chemotherapy vs no therapy) and the hormone receptor status (positive vs negative).
Patients (groups A-C) undergo bioavailable estradiol measurements, PET scans, and MRI scans at baseline and 1 and 18 months after treatment. Patients also undergo cognitive, neuropsychological, sociodemographic, and quality of life assessments using a battery of study tests and questionnaires at baseline and at 1, 9, and 18 months after treatment. Group D participants (controls) undergo the same testing at equivalent intervals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755313
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Hope S. Rugo, MD||University of California, San Francisco|