Effects of Chemotherapy on Brain Structure and Function
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Observational
Observational Model: Case Control, Time Perspective: Prospective
Change in glucose metabolism
Up to 18 months after treatment
No
Hope S. Rugo, MD
Principal Investigator
University of California, San Francisco
United States: Food and Drug Administration
CDR0000613050
NCT00755313
May 2007
December 2014
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |