UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044390 |
|---|---|
| Receipt number | R000048719 |
| Scientific Title | Impact of cancer cachexia progression on CYP3A4 and OATP1B activity: Quantitative analysis using endogenous biomarker |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2025/12/04 09:02:48 |
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Basic information
Public title
Impact of cancer cachexia progression on CYP3A4 and OATP1B activity: Quantitative analysis using endogenous biomarker
Acronym
Impact of cancer cachexia progression on CYP3A4 and OATP1B activity: Quantitative analysis using endogenous biomarker
Scientific Title
Impact of cancer cachexia progression on CYP3A4 and OATP1B activity: Quantitative analysis using endogenous biomarker
Scientific Title:Acronym
Impact of cancer cachexia progression on CYP3A4 and OATP1B activity: Quantitative analysis using endogenous biomarker
Region
| Japan |
Condition
Condition
Cancer Cachexia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Elucidate the association of cancer cachexia progression on CYP3A4 and OATP1B activity
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the effect of cancer cachexia progression on CYP3A4 and OATP1B activity
Key secondary outcomes
1) Relationship between cancer cachexia progression and plasma concentration, the endogenous substrate for CYP3A4.
2) Relationship between cancer cachexia progression and plasma concentration, the endogenous substrate for OATP1B.
3) Relationship between plasma concentration of the endogenous substrate and inflammatory cytokine concentration.
4) Relationship between plasma concentration of the endogenous substrate and inflammatory cytokine concentration.
5) Relationship between Phenotype of CYP3A5 gene polymorphism and plasma concentration of the endogenous substrate, various inflammatory cytokine concentrations, and cancer cachexia progression.
6) Relationship between Phenotype of OATP1B gene polymorphism and plasma concentration of the endogenous substrate, various inflammatory cytokine concentrations, and cancer cachexia progression.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who can be evaluated for the progression of cancer cachexia.
Key exclusion criteria
Patients who are concomitantly using drugs that induce or inhibit CYP3A and OATP1B. Patients with hepatic/renal dysfunction.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Sumimoto |
Organization
Oita University Hospital
Division name
Clinical pharmacy
Zip code
8705593
Address
1-1, Idaigaoka, Hasama, Yufu, Oita, Japan
TEL
0975866112
sumimoto@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Sumimoto |
Organization
Oita University Hospital
Division name
Clinical pharmacy
Zip code
8705593
Address
1-1, Idaigaoka, Hasama, Yufu, Oita, Japan
TEL
0975866112
Homepage URL
sumimoto@oita-u.ac.jp
Sponsor or person
Institute
facluty of medicine, Oita University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Medication Use Analysis and Clinical Research, Meiji Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Oita University
Address
1-1, Idaigaoka, Hasama, Yufu, Oita, Japan
Tel
0975866380
rinrikenkyu@oita-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
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.3649
Publication of results
Partially published
Result
URL related to results and publications
https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.3649
Number of participants that the trial has enrolled
114
Results
Impact of cancer cachexia progression on OATP1B transport activity; the decreased OATP1B activity in patients with cancer cachexia may be influenced by the inflammatory cytokines or some other factors that are increased by the progression of cancer cachexia, rather than by OATP1B polymorphisms and CMPF.
Results date posted
| 2025 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
According to the definitions and classification developed by international consensus,8 40 patients were classified as pre-cachexia, 39 patients as cachexia, and 35 patients as refractory cachexia.
Participant flow
A cross-sectional study was conducted recruiting patients with cancer cachexia who visited the Department of Oncology and Hematology at Oita University Hospital. The exclusion criteria were as follows: body mass index > 30 kg/m2; total bilirubin > 1.5 mg/dL; serum creatinine > 2.0 mg/dL; patients on OATP1B inhibitors such as rifampicin, cyclosporine A, and clarithromycin; and patients with hematological malignancy.
Adverse events
None
Outcome measures
Impact of cancer cachexia progression on OATP1B transport activity: Quantitative analysis using an endogenous biomarker.
Impact of cancer cachexia progression on CYP3A activity: Quantitative analysis using an endogenous biomarker.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
Other
Other related information
Study design:Case-control study
Management information
Registered date
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048719
