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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date September 17, 2008
First Posted Date September 18, 2008
Last Update Posted Date November 24, 2017
Study Start Date May 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2012)
Change in glucose metabolism [ Time Frame: Up to 18 months after treatment ]
Original Primary Outcome Measures
 (submitted: September 17, 2008)
Change in glucose metabolism
Change History
Current Secondary Outcome Measures
 (submitted: September 21, 2012)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: September 17, 2008)
  • MRI measures of the brain (hippocampal volume, cortical gray matter volume, white matter signal hyperintensities, ventricular volume, whole brain volume)
  • 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 ...
  • Cognitive assessments over time by FACIT-B, Ham-D, BDI-II, STAI, FSI, and MASQ, demographic and medical data
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
Official Title Effects of Chemotherapy on Brain Structure and Function
Brief 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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 1, 2013)
81
Original Estimated Enrollment
 (submitted: September 17, 2008)
100
Actual Study Completion Date June 6, 2014
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00755313
Other Study ID Numbers CDR0000613050
UCSF-06803
UCSF-H6961-29940-02B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2017