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Effects of Chemotherapy on Brain Structure and Function
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.
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.
Age
35 - 80 years
Sex
FEMALE
Healthy Volunteers
Yes
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Start Date
May 1, 2007
Primary Completion Date
September 1, 2012
Completion Date
June 6, 2014
Last Updated
November 24, 2017
81
ACTUAL participants
trastuzumab
BIOLOGICAL
aromatase inhibition therapy
DRUG
carboplatin
DRUG
cyclophosphamide
DRUG
docetaxel
DRUG
doxorubicin hydrochloride
DRUG
metabolic assessment
OTHER
questionnaire administration
OTHER
study of socioeconomic and demographic variables
OTHER
cognitive assessment
PROCEDURE
positron emission tomography
PROCEDURE
fludeoxyglucose F 18
RADIATION
Lead Sponsor
University of California, San Francisco
Collaborators
NCT04550494
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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