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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022448
Receipt No. 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 2018/05/28

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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
Middle name
Last name Akira Inoue
Organization Tohoku University School of Medicine
Division name Department of Palliative Medicine
Zip code
Address 2-1, Seiryocho, Aobaku, Sendai
TEL 022-717-7366
Email akira.inoue.b2@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Inoue
Organization Tohoku University School of Medicine
Division name Department of Palliative Medicine
Zip code
Address 2-1, Seiryocho, Aobaku, Sendai
TEL 022-717-7366
Homepage URL
Email akira.inoue.b2@tohoku.ac.jp

Sponsor
Institute North-East Japan Study Group
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2016 Year 05 Month 25 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025871

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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