Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
|ClinicalTrials.gov Identifier: NCT00755313|
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : November 24, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Chemotherapeutic Agent Toxicity Cognitive/Functional Effects Fatigue Long-term Effects Secondary to Cancer Therapy in Adults Neurotoxicity Psychosocial Effects of Cancer and Its Treatment||Biological: trastuzumab Drug: aromatase inhibition therapy Drug: carboplatin Drug: cyclophosphamide Drug: docetaxel 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|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||81 participants|
|Official Title:||Effects of Chemotherapy on Brain Structure and Function|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||June 6, 2014|
- Change in glucose metabolism [ Time Frame: Up to 18 months after treatment ]
- 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 ]
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|