Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|