Breast cancer
Conditions
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
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
| Measure | Time 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
| Measure | Time 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