UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061930 |
|---|---|
| Receipt number | R000070853 |
| Scientific Title | Study on interindividual variability in pharmacokinetics, pharmacodynamics and tolerability of orexin receptor antagonists in patients with cancer |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/06/16 19:53:58 |
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Basic information
Public title
Study on interindividual variability in pharmacokinetics, pharmacodynamics and tolerability of orexin receptor antagonists in patients with cancer
Acronym
Orexin receptor antagonist PK-PD and tolerability in patients with cancer
Scientific Title
Study on interindividual variability in pharmacokinetics, pharmacodynamics and tolerability of orexin receptor antagonists in patients with cancer
Scientific Title:Acronym
Orexin receptor antagonist PK-PD and tolerability in patients with cancer
Region
| Japan |
Condition
Condition
Insomnia in patients with cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to explore the interindividual variability in pharmacokinetics, clinical effects on sleep-related symptoms, and tolerability of orexin receptor antagonists in patients with cancer, focusing on cancer cachexia, inflammatory cytokines, CYP3A activity, genetic polymorphisms, and concomitant medications.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma concentrations of orexin receptor antagonists on day 7 or later after initiation of treatment
Key secondary outcomes
1. Sleep-related symptoms, including nocturnal awakenings and daytime sleepiness
2. Genotyping, including CYP3A5
3. CYP3A activity marker, including 4beta-hydroxycholesterol
4. Cancer cachexia status assessed by EPCRC classification and Glasgow Prognostic Score
5. Inflammatory cytokines and inflammatory/nutritional markers, including IL-6, CRP, albumin, and total cholesterol
6. Effects of concomitant medications
7. Adverse reactions, including somnolence, dizziness, falls, and other clinically relevant symptoms
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older with a confirmed diagnosis of solid cancer
2. Patients treated with orexin receptor antagonists
3. Patients treated in the outpatient or inpatient setting at Shinshu University Hospital
4. Patients from whom written informed consent was obtained
Key exclusion criteria
1. Patients using orexin receptor antagonists on an as-needed basis
2. Patients considered not to have reached steady-state plasma concentrations of orexin receptor antagonists
3. Patients who have undergone hematopoietic stem cell transplantation
4. Patients judged by the principal investigator to be inappropriate for the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Naito |
Organization
Shinshu University Hospital
Division name
Department of Pharmacy
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0263373022
naitou@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Sakaue |
Organization
Shinshu University Hospital
Division name
Department of Pharmacy
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0263373022
Homepage URL
sakaue@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
MEXT, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
Tel
0263373099
mdrinri@shinshu-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 | 06 | Month | 16 | 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
81
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical laboratory values such as total protein, serum albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen, serum creatinine, C-reactive protein, total cholesterol, IL-6, and 4beta-hydroxycholesterol are collected to evaluate clinical responses during this study.
Management information
Registered date
| 2026 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070853
