UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062938 |
|---|---|
| Receipt number | R000072011 |
| Scientific Title | Immediate changes in sleepiness and sustained attention following intravenous chemotherapy: a single-center prospective pilot study |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/15 22:16:29 |
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Basic information
Public title
Immediate changes in sleepiness and sustained attention following intravenous chemotherapy: a single-center prospective pilot study
Acronym
A prospective study of acute chemobrain
Scientific Title
Immediate changes in sleepiness and sustained attention following intravenous chemotherapy: a single-center prospective pilot study
Scientific Title:Acronym
A prospective study of immediate-term CRCI
Region
| Japan |
Condition
Condition
Pancreatic cancer and gynecologic cancers (ovarian, endometrial, and cervical cancers)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are twofold: (1) to investigate, using a simple screening, factors that may affect driving performance in patients undergoing chemotherapy, including cognitive function and symptoms of anxiety and depression; and (2) to assess changes in sleepiness and sustained attention before and after chemotherapy administration using a tablet device. The treatment regimens evaluated in this study are gemcitabine plus nab-paclitaxel (GnP) and paclitaxel plus carboplatin (TC).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Median reaction time (RT) on the psychomotor vigilance test (PVT) before and 15 and 60 minutes after chemotherapy administration.
Key secondary outcomes
PVT reaction speed (1000/RT), the number of lapses (defined as RT > 500 ms or RT > 2 times the median RT), and the Karolinska Sleepiness Scale (KSS).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients will undergo assessments including the KSS, PVT, trail making test part B (TMT-B), Hospital Anxiety and Depression Scale (HADS), and a questionnaire assessing sleep status. The KSS and PVT will be assessed before and 15 and 60 minutes after chemotherapy administration. The TMT-B, HADS, and sleep status questionnaire will be assessed before chemotherapy administration. The measurement conditions will be standardized as much as possible. Specifically, patients and the nurses in charge will be instructed in advance to avoid sleeping during chemotherapy administration, excessive physical activity, and caffeine intake. During the measurements, they will also be instructed to avoid conversations with others, use of mobile phones or other devices, and other unnecessary external stimuli. If any of these factors cannot be avoided, they will be recorded.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo GnP therapy or TC with or without other therapy between the date of study approval and March 31, 2030.
Key exclusion criteria
(1) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of >2.
(2) The presence of apparent higher-order cognitive impairment due to brain metastases or a history of neurological disease or other conditions.
(3) Grade >2 peripheral neuropathy.
(4) Use of sleeping medication, including as-needed medication, or other medications with drowsiness as a side effect from 2 days before the study assessment through the day of chemotherapy administration.
(5) Inability to provide written informed consent to participate in this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ikesue |
Organization
Nagoya University Hospital
Division name
Department of Hospital Pharmacy
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, Japan
TEL
052-744-2674
pharmacy@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Minamishima |
Organization
Nagoya University Hospital
Division name
Department of Hospital Pharmacy
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, Japan
TEL
052-744-2674
Homepage URL
pharmacy@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Ethics Committee of Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, Japan
Tel
052-744-2423
ethics@med.nagoya-u.ac.jp
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
| 2026 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072011
