Breast Cancer Clinical Trial
Official title:
Effects of Chemotherapy on Brain Structure and Function
Verified date | November 2017 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | June 6, 2014 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 80 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of breast cancer, meeting 1 of the following criteria: - Group A - Stage I, II, or III invasive disease - Hormone receptor-positive disease - Planned adjuvant chemotherapy including an anthracycline and taxane using either dose-dense or docetaxel, doxorubicin hydrochloride, and cyclophosphamide (TAC) regimens with or without trastuzumab (Herceptin®) for 4 months; docetaxel and cyclophosphamide (TC) with or without trastuzumab for 3 months; doxorubicin hydrochloride and cyclophosphamide (AC) for 3 months; or doxorubicin hydrochloride, carboplatin, and trastuzumab (TCH) for 4 months (trastuzumab may be given for 1 year and is not considered chemotherapy for the purpose of this study) - Planned treatment with adjuvant aromatase inhibitors (AI) for 5 years - Group B - Stage I or II invasive disease - Planned treatment with adjuvant AI with or without radiotherapy - Group C - Stage I, II, or III disease - Hormone-receptor negative - Planned adjuvant chemotherapy as in group A - No treatment with AI planned - Group D - Healthy controls free of any major medical or psychiatric disorders - Not taking prescription medications, including hormone-replacement therapy, or other substances that might influence performance on neuropsychological tests - Balanced with the patient groups on age, education, ethnicity, and sociodemographic background PATIENT CHARACTERISTICS: - No history of psychiatric illness other than minor depression - No history of psychiatric illness other than minor depression in immediate family members - No history of neurologic disease - No history of drug or alcohol abuse - No significant medical illness other than breast cancer - No heart pacemaker or metallic implants or particles in the body - No heart rhythm disturbance - No claustrophobia - No prior serious head injury - No tattoos or permanent cosmetics - No unremovable body jewelry - No cognitive impairment - Able to read and speak English - No condition that compromises compliance with the objectives and procedures of this study, as judged by the principal investigator PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior chemotherapy, CNS radiotherapy, or intrathecal therapy - Premenopausal women receiving aromatase inhibitors must also be receiving ovarian suppression - No concurrent narcotics or major antipsychotic medications that may impair cognition |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in glucose metabolism | Up to 18 months after treatment | ||
Secondary | MRI measures of the brain (hippocampal volume, cortical gray matter volume, white matter signal hyperintensities, ventricular volume, whole brain volume) | Up to 18 months after treatment | ||
Secondary | 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 ... | Up to 18 months after treatment | ||
Secondary | Cognitive assessments over time by FACIT-B, Ham-D, BDI-II, STAI, FSI, and MASQ, demographic and medical data | Up to 18 months after treatment |
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