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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028877
Receipt No. R000033050
Scientific Title Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial
Date of disclosure of the study information 2017/08/31
Last modified on 2018/02/28

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Basic information
Public title Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial
Acronym Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial
Scientific Title Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial
Scientific Title:Acronym Dexamethasone for cancer-related fatigue in advanced cancer patients - multi-center phase II trial
Region
Japan

Condition
Condition cancer (cancer-related fatigue)
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the efficacy of dexamethasone 8mg p.o or 6.6mg i.v. for moderate to severe cancer-related fatigue
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of FACIT-Fatigue subscale score at day 8
Key secondary outcomes The change of fatigue score
The proportion of achievement of individual therapeutic goal
The change of symptom scores
the change of performance status
Patients satisfaction
Adverse events

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 1. Dexamethasone 8mg by mouth once a day day 1-7, 4mg for day 8-14
2. Dexamethasone 6.6mg by venous injection once a day day 1-7, 3.3mg for day 8-14
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 A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue score 4 and more using NRS(0-10)
20 years and older
Prognosis over 30 days
No anti-cancer treatment plan
Inpatient receiving palliative care
Performance status 0-3
Conprehension of Japanese
Provided written informed consent
Key exclusion criteria Patients received corticosteroid therapies within 1 week
Patients received surgery within 4 week
Patients received radiation therapy within 2 week
Patients received anti-tumor treatment within 2 week
Patients had diabetes mellitus, active infection and cognitive disorder



Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomofumi Miura
Organization National Cancer Center Hospital East
Division name Department of Palliative Medicine
Zip code
Address Kashiwanoha 6-5-1, Kashiwa-city, Chiba-prefecture
TEL 04-7133-1111
Email tomiura@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomofumi Miura
Organization National Cancer Center Hospital East
Division name Department of Palliative Medicine
Zip code
Address Kashiwanoha 6-5-1, Kashiwa-city, Chiba-prefecture
TEL 04-7133-1111
Homepage URL
Email tomiura@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization AMED(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
Address
Tel
Email

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
2017 Year 08 Month 31 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 29 Day
Last modified on
2018 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033050

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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