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

Breast Cancer Clinical Trial

Official title:

Effects of Chemotherapy on Brain Structure and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755313
• Other study ID #: CDR0000613050
• Secondary ID: UCSF-06803UCSF-H
• Status: Completed
• Phase: N/A
• First received: September 17, 2008
• Last updated: November 21, 2017
• Start date: May 2007
• Est. completion date: June 6, 2014

Study information

• Verified date: November 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 6, 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapeutic Agent Toxicity
• Cognitive/Functional Effects
• Fatigue
• Long-term Effects Secondary to Cancer Therapy in Adults
• Neurotoxicity
• Neurotoxicity Syndromes
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Biological:
• trastuzumab

Drug:
• aromatase inhibition therapy

• carboplatin

• cyclophosphamide

• docetaxel

• doxorubicin hydrochloride

Other:
• metabolic assessment

• questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• cognitive assessment

• positron emission tomography

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose metabolism		Up to 18 months after treatment
Secondary	MRI measures of the brain (hippocampal volume, cortical gray matter volume, white matter signal hyperintensities, ventricular volume, whole brain volume)		Up to 18 months after treatment
Secondary	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 ...		Up to 18 months after treatment
Secondary	Cognitive assessments over time by FACIT-B, Ham-D, BDI-II, STAI, FSI, and MASQ, demographic and medical data		Up to 18 months after treatment