UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036383 |
|---|---|
| Receipt number | R000041452 |
| Scientific Title | Impact of CINV on Muscle Depletion during Cisplatin based treatment |
| Date of disclosure of the study information | 2019/04/02 |
| Last modified on | 2019/04/02 18:52:20 |
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Basic information
Public title
Impact of CINV on Muscle Depletion during Cisplatin based treatment
Acronym
Impact of CINV on Muscle Depletion during Cisplatin based treatment
Scientific Title
Impact of CINV on Muscle Depletion during Cisplatin based treatment
Scientific Title:Acronym
Impact of CINV on Muscle Depletion during Cisplatin based treatment
Region
| Japan |
Condition
Condition
Thoracic Malignancy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify whether reduced food intake due to chemotherapy-induced nausea and vomiting (CINV) or anorexia contributes to muscle wasting.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
changes of skeletal muscle mass in three months from the start of treatment
Key secondary outcomes
we explored clinicopathologic factors other than CINV or CIA associated with decrease of skeletal muscle mass.
Base
Study type
Others,meta-analysis etc
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
Male and Female
Key inclusion criteria
Eligible patients are 20 years old or older, Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, histologically or cytologically confirmed thoracic malignant disease, and scheduled to receive first-course cisplatin (60 mg/m2 and more) combination therapy.
Key exclusion criteria
Lack of CT scan three months later from the start of treatment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Miyawaki |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
e.miyawaki@scchr.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Miyawaki |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
e.miyawaki@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
Tel
055-989-5222
e.miyawaki@scchr.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
| 2019 | Year | 04 | Month | 02 | 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
29
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is the post-hoc analysis of the phase II clinical trial of antiemetic treatment for CINV (trial registration number, UMIN000024676). Patients were prospectively recruited between May and October 2015 at Shizuoka Cancer Center.
Management information
Registered date
| 2019 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
