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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00755313
First received: September 17, 2008
Last updated: November 1, 2013
Last verified: November 2013

September 17, 2008
November 1, 2013
May 2007
September 2012   (final data collection date for primary outcome measure)
Change in glucose metabolism [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
Change in glucose metabolism [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00755313 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • MRI measures of the brain (hippocampal volume, cortical gray matter volume, white matter signal hyperintensities, ventricular volume, whole brain volume) [ Designated as safety issue: No ]
  • 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 ... [ Designated as safety issue: No ]
  • Cognitive assessments over time by FACIT-B, Ham-D, BDI-II, STAI, FSI, and MASQ, demographic and medical data [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
Effects of Chemotherapy on Brain Structure and Function

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

women with newly diagnosed, early stage breast cancer

  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
December 2014
September 2012   (final data collection date for primary outcome measure)

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
Female
35 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00755313
CDR0000613050, UCSF-06803, UCSF-H6961-29940-02B
Yes
University of California, San Francisco
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
University of California, San Francisco
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP