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Impairments in subjective cognition associated with chemotherapy in patients with breast cancer: a preliminary prospective open study

Impairments in subjective cognition associated with chemotherapy in patients with breast cancer: a preliminary prospective open study - Impairments in subjective cognition associated with chemotherapy for breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009203
Enrollment
40
Registered
2012-10-29
Start date
2012-10-28
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Breast cancer

Interventions

Subjective cognitive tests including the BADS, RBMT, CAS and CFQ, and objective cognitive tests including LNS and SS will be performed within 4 weeks after chemotherapy (T1) and 6 months after T1 (T2)

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Women with breast cancer who underwent neo-adjuvant chemotherapy. 2) Women capable of consent to this study.

Exclusion criteria

Exclusion criteria: 1) History of radiotherapy. 2) History of other malignant tumors. 3) Comorbidity of serious physical or neuropsychiatric diseases. 4) History of substance use disorders.

Design outcomes

Primary

MeasureTime frame
The primary outcomes are subjective cognitive function scores in the Behavioural Assessment of the Dysexective Syndrome (BADS) (executive function), Rivermead Behavioral Memory Test (RBMT) (behavioral memory), Clinical Assessment for Spontaneity (CAS) (spontaneity) Cognitive Failures Questionnaire (CFQ) (attention). We will perform them within 4 weeks after chemotherapy (T1) and 6 months after T1 (T2), respectively.

Secondary

MeasureTime frame
The secondary outcome is objective working memory scores in the Letter-Number Sequencing (LNS) and Spatial Span (SS). The other secondary outcome are Tumor Necrosis Factor-alfa (TNF-alfa) and High sensitivity C-reactive protein (hsCRP), Brain-derived neurotrophic factor (BDNF), and S-100 protein beta submit (S100B). We will perform them within 4 weeks after chemotherapy (T1) and 6 months after T1 (T2), respectively.

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026