NCT00755313

Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer

Effects of Chemotherapy on Brain Structure and Function

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 35 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-05-01
• Primary completion: 2012-09-01
• Completion: 2014-06-06
• First posted: 2008-09-18
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States