UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer
Title of the study (Brief title)	The influence of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery Psychiatry
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will investigate the impact of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcomes are objective cognitive function scores in verbal fluency tasks, a part of Wechsler Memory Scale-Revised (WMS-R), Trail Making Test A/B (TMT-A/B), a part of Wechsler Adult Intelligence Scale-III (WAIS-III). We will perform them before chemotherapy (T1), within a week after the end of 1st kind chemotherapy (T2), within a week after the end of 2nd kind chemotherapy (T3), and more than 3 months after the end of 2nd kind chemotherapy (T4).
Key secondary outcomes	The secondary outcomes are subjective cognitive function scores in Everyday Memory Checklist, QOL scores in Functional Assessment of Cancer Therapy-Breast (FACT-B), psychiatric symptoms scores in Hospital Anxiety and Depression Scale (HADS). We will perform them before chemotherapy (T1), within a week after the end of 1st kind chemotherapy (T2), within a week after the end of 2nd kind chemotherapy (T3), and more than 3 months after the end of 2nd kind chemotherapy (T4).

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) Female patients with incipient breast cance 2) The first use of our outpatient chemotherapy room during this study
Key exclusion criteria	1) Incapable of consent to this study 2) History of chemotherapy during admission 3) History of other malignant tumors 4) History of radiotherapy 5) Existence of brain metastasis
Target sample size	20

Research contact person
Name of lead principal investigator	Tetsuro Omori
Organization	Institute of Health Biosciences, The University of Tokushima Graduate School
Division name	Psychiatry
Address	3-8-15 Kuramoto-cho Tokushima, Tokushima
TEL	088-633-7130
Email	seishinka@tokushima-u.ac.jp

Public contact
Name of contact person	Yukio Tada
Organization	Tokushima University Hospital
Division name	Psychiatry
Address	2-50-1 Kuramoto-cho Tokushima, Tokushima
TEL	088-631-3111
Homepage URL
Email	ytada-psy@umin.net

Sponsor
Institute	Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization	Institute of Health Biosciences, The University of Tokushima Graduate School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 22 Day
Anticipated trial start date	2015 Year 01 Month 05 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Objective cognitive function tests, a subjective cognitive test, a QOL test, and a psychiatric symptoms test will be performed before chemotherapy (T1), within a week after the end of 1st kind chemotherapy (T2), within a week after the end of 2nd kind chemotherapy (T3), and over 3 months after the end of 2nd kind chemotherapy (T4). Objective cognitive tests will require about 1 hour.

Management information
Registered date	2015 Year 01 Month 20 Day
Last modified on	2019 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018887