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

NCT00755313 | Completed DMC

• 3 other identifiers: CDR0000613050UCSF-06803UCSF-H6961-29940-02B
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

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 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

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

• 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

Interventions

trastuzumab BIOLOGICAL

aromatase inhibition therapy DRUG

carboplatin DRUG

cyclophosphamide DRUG

docetaxel DRUG

doxorubicin hydrochloride DRUG

metabolic assessment OTHER

questionnaire administration OTHER

study of socioeconomic and demographic variables OTHER

cognitive assessment PROCEDURE

positron emission tomography PROCEDURE

fludeoxyglucose F 18 RADIATION

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Neurotoxicity Syndromes

Interventions

Trastuzumab; Aromatase Inhibitors; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Mental Status and Dementia Tests; Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars

Study Officials

• Hope S. Rugo, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

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 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: June 6, 2014
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (1)