Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

cognitive/functional effectsfatiguelong-term effects secondary to cancer therapy in adultspsychosocial effects of cancer and its treatmentchemotherapeutic agent toxicityneurotoxicitystage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerestrogen receptor-negative breast cancerestrogen receptor-positive breast cancerprogesterone receptor-negative breast cancerprogesterone receptor-positive breast cancer

Outcome Measures

Primary Outcomes (1)

Change in glucose metabolism
Up to 18 months after treatment

Secondary Outcomes (3)

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
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

Interventions

trastuzumabBiological

aromatase inhibition therapyDrug

positron emission tomographyProcedure

Eligibility Criteria

Age35 Years - 80 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

women with newly diagnosed, early stage breast cancer

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

Sponsors & Collaborators

University of California, San Francisco
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

MeSH Terms

Conditions

Breast NeoplasmsFatigueNeurotoxicity Syndromes

Interventions

TrastuzumabAromatase InhibitorsCarboplatinCyclophosphamideDocetaxelDoxorubicinMental Status and Dementia TestsMagnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

Hope S. Rugo, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Enrollment

81 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

May 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations