Clinical trial · Observational
Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
Effects of Chemotherapy on Brain Structure and Function
NCT00755313CI-TRIAL-00030521completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Long-term Effects Secondary to Cancer Therapy in Adults | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aromatase inhibition therapy | Drug | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cognitive assessment | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| metabolic assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in glucose metabolism
- timeFrame
- Up to 18 months after treatment
Secondary outcomes (3)
- measure
- MRI measures of the brain (hippocampal volume, cortical gray matter volume, white matter signal hyperintensities, ventricular volume, whole brain volume)
- timeFrame
- Up to 18 months after treatment
- measure
- 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 ...
- timeFrame
- Up to 18 months after treatment
- measure
- Cognitive assessments over time by FACIT-B, Ham-D, BDI-II, STAI, FSI, and MASQ, demographic and medical data
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 cognitionReferences
Publications (0)
Data not yet available
No reference posted for this study.