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

Unravelling brain mechanisms of cognitive impairment in breast cancer patients during adjuvant endocrine treatment - Effects of hormonal treatment for breast cancer on brain and cognition

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37354
Enrollment
150
Registered
2012-04-25
Start date
2012-06-27
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

None listed

Sponsors

Radboud Universiteit Nijmegen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Neuropsychological measures that quantify cognitive functioning, and parameters derived from brain imaging methods (MEG and fMRI).

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)