UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028877 |
|---|---|
| Receipt number | 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 | 2023/09/03 09:16:03 |
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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 | Tomofumi |
| Middle name | |
| Last name | Miura |
Organization
National Cancer Center Hospital East
Division name
Department of Palliative Medicine
Zip code
2778577
Address
Kashiwanoha 6-5-1, Kashiwa-city, Chiba-prefecture
TEL
04-7133-1111
tomiura@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Miura |
Organization
National Cancer Center Hospital East
Division name
Department of Palliative Medicine
Zip code
2778577
Address
Kashiwanoha 6-5-1, Kashiwa-city, Chiba-prefecture
TEL
04-7133-1111
Homepage URL
tomiura@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
AMED(Japan)
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
IRB for National Cancer Center
Address
Kashiwanoha 6-5-1, Kashiwa, Chiba
Tel
0471331111
not@released.
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
Please see (https://www.liebertpub.com/doi/full/10.1089/pmr.2021.0053)
Publication of results
Published
Result
URL related to results and publications
Please see (https://www.liebertpub.com/doi/full/10.1089/pmr.2021.0053)
Number of participants that the trial has enrolled
32
Results
Please see the abstract (https://www.liebertpub.com/doi/full/10.1089/pmr.2021.0053)
Results date posted
| 2023 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see the abstract (https://www.liebertpub.com/doi/full/10.1089/pmr.2021.0053)
Participant flow
we enrolled participants in 5 institutes
Adverse events
Please see the abstract (https://www.liebertpub.com/doi/full/10.1089/pmr.2021.0053)
Outcome measures
Please see the abstract (https://www.liebertpub.com/doi/full/10.1089/pmr.2021.0053)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 04 | Day |
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
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033050
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| Registered date | File name |
| Research case data | |
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