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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Chemotherapy on Brain Structure and Function

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in glucose metabolism [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

women with newly diagnosed, early stage breast cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755313

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00755313     History of Changes
Other Study ID Numbers: CDR0000613050, UCSF-06803, UCSF-H6961-29940-02B
Study First Received: September 17, 2008
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
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

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neurotoxicity Syndromes
Breast Diseases
Chemically-Induced Disorders
Neoplasms
Neoplasms by Site
Nervous System Diseases
Poisoning
Signs and Symptoms
Skin Diseases
Cyclophosphamide
Doxorubicin
Fluorodeoxyglucose F18
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014