UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022448 |
|---|---|
| Receipt number | R000025871 |
| Scientific Title | Randomized phase II study of dexamethason for anorexia in patients with advanced lung cancer |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2025/12/01 10:12:49 |
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Basic information
Public title
Randomized phase II study of dexamethason for anorexia in patients with advanced lung cancer
Acronym
Randomized phase II of dexamethason for anorexia in lung cancer patients
Scientific Title
Randomized phase II study of dexamethason for anorexia in patients with advanced lung cancer
Scientific Title:Acronym
Randomized phase II of dexamethason for anorexia in lung cancer patients
Region
| Japan |
Condition
Condition
Advanced lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of dexamethason with different dose
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS of anorexia at day 7
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexamethason 1mg
Interventions/Control_2
Dexamethason 4mg
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
1. Advanced lung cancer with grade3 (NCI-CTC) anorexia
2. Performance status 2-3
3. 20 years old or older
4. No chemotherapy within 2 weeks (>12 weeks responder with EGFR- or ALK-TKI were eligible)
5. Addequate organ function
6. >2 months life expectancy
7. Written informed consent
Key exclusion criteria
1. Contraindication for steroid use
2. Already use of steroid for other disease
3. Uncontrolled co-morbidities such as heart failure or renal failure
4. Symptomatic brain metastasis
5. Uncontrolled cancer pain
6. Other drugs for anorexia within 2 weeks
7. Acute exacerbation of lung cancer
8. Suspicios of bowel obstruction
9. Unable to answer questiones regarding appetite and QOL
10. Other inappropriate conditions for clinical trial
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Inoue |
Organization
Tohoku University School of Medicine
Division name
Department of Palliative Medicine
Zip code
980-8575
Address
2-1, Seiryocho, Aobaku, Sendai
TEL
022-717-7366
akira.inoue.b2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Inoue |
Organization
Tohoku University School of Medicine
Division name
Department of Palliative Medicine
Zip code
9893204
Address
2-1, Seiryocho, Aobaku, Sendai
TEL
022-717-7366
Homepage URL
akira.inoue.b2@tohoku.ac.jp
Sponsor or person
Institute
North-East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
North-East Japan Study Group
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
Tohoku Certified Review Board of Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
office@nrs.hosp.tohoku.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
| 2016 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025871
