nravelling brain mechanisms of cognitive impairment in breast cancer patients during adjuvant endocrine treatment

Completed

Conditions: breast cancer
10006291
10006232

Registration Number: NL-OMON37354

Lead Sponsor: Radboud Universiteit Nijmegen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

* Women of age * 18 years.
* Histologically/cytologically confirmed adenocarcinoma of the breast followed by intended curative surgery and if indicated, also radiotherapy and chemotherapy.
* ER + and/or PgR + receptor status.
* Indication for treatment with tamoxifen or anastrozole according to the Dutch guidelines.
* Disease-free, as defined by the absence of somatic disease activity parameters.
* Accessible for follow-up for duration of study.
* Karnofsky 80-100.
* Written informed consent.

Exclusion Criteria

* Palliative treatment or inflammatory breast cancer .
* Evidence of distant metastasis (M1).
* Concomitant or previous malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin.
* Hormone Replacement Therapy for treatment of menopausal symptoms, not stopped at least 4 weeks prior to inclusion in the study.
* Current psychological or psychiatric treatment.
* Treatment with anti-depressive drugs, anti-epileptic drugs, benzodiazepines.
* Insufficient command of the Dutch language to fill out questionnaires.
* Contra-indication for MR examinations (e.g. claustrophobia).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Neuropsychological measures that quantify cognitive functioning, and parameters<br /><br>derived from brain imaging methods (MEG and fMRI).</p><br>

Secondary Outcome Measures