Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
Condition: 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
MeSH terms: Breast Neoplasms; Neurotoxicity Syndromes; Fatigue
Study type: Observational

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.
    

Intervention name(s): trastuzumab; aromatase inhibition therapy; carboplatin; cyclophosphamide; docetaxel; doxorubicin hydrochloride; metabolic assessment; questionnaire administration; study of socioeconomic and demographic variables; cognitive assessment; positron emission tomography; fludeoxyglucose F 18
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Other; Other; Other; Procedure; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Docetaxel; Doxorubicin; Liposomal doxorubicin; Trastuzumab; Fluorodeoxyglucose F18; Aromatase Inhibitors
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women with newly diagnosed, early stage breast cancer
      
Keywords: cognitive/functional effects; fatigue; long-term effects secondary to cancer therapy in adults; psychosocial effects of cancer and its treatment; chemotherapeutic agent toxicity; neurotoxicity; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; estrogen receptor-negative breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-negative breast cancer; progesterone receptor-positive breast cancer