Breast CancerNCT00755313
Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
An observational study of Breast Cancer and Chemotherapeutic Agent Toxicity, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects
- What is being tested?
- trastuzumab, aromatase inhibition therapy and carboplatin
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to 6 Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Effects of Chemotherapy on Brain Structure and Function
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.
Read the 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.
- Conditions
- Breast Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Fatigue, Long-term Effects Secondary to Cancer Therapy in Adults, Neurotoxicity
- Being tested
- trastuzumab, aromatase inhibition therapy, carboplatin, cyclophosphamide, docetaxel
- 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
- Medical subject headings
- Breast Neoplasms, Fatigue, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
aromatase inhibition therapyDrug
carboplatinDrug
cyclophosphamideDrug
docetaxelDrug
metabolic assessmentOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
cognitive assessmentProcedure or surgery
positron emission tomographyProcedure or surgery
fludeoxyglucose F 18Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose metabolism
Measured: 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)
Measured: 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 ...
Measured: 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
Measured: Up to 18 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionSep 2012
- Study completion6 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hope S. Rugo, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755313
- Sponsor's protocol ID
- CDR0000613050
- Other IDs
- UCSF-06803, UCSF-H6961-29940-02B
- Status last verified
- Nov 2017
- First submitted
- 17 Sep 2008
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chemotherapy on Brain Structure and Function
- ClinicalTrials.gov ID
- NCT00755313
- Acronym / sponsor ID
- CDR0000613050
- Conditions
- Breast Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Fatigue, Long-term Effects Secondary to Cancer Therapy in Adults, Neurotoxicity
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- 6 Jun 2014 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women with newly diagnosed, early stage breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | – |
| positron emission tomography | Procedure or surgery | – |
| fludeoxyglucose F 18 | Radiation | – |
Primary outcome
Change in glucose metabolism
Time frame: Up to 18 months after treatment
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hope S. Rugo, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapeutic Agent Toxicity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose metabolism (time frame: Up to 18 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.