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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036383
Receipt No. 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

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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
Email 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
Email e.miyawaki@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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