Unique ID issued by UMIN | UMIN000022448 |
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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 | 2018/05/28 09:35:15 |
Randomized phase II study of dexamethason for anorexia in patients with advanced lung cancer
Randomized phase II of dexamethason for anorexia in lung cancer patients
Randomized phase II study of dexamethason for anorexia in patients with advanced lung cancer
Randomized phase II of dexamethason for anorexia in lung cancer patients
Japan |
Advanced lung cancer
Pneumology | Hematology and clinical oncology | Chest surgery |
Malignancy
NO
To evaluate the efficacy and safety of dexamethason with different dose
Safety,Efficacy
NRS of anorexia at day 7
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Treatment
Medicine |
Dexamethason 1mg
Dexamethason 4mg
20 | years-old | <= |
Not applicable |
Male and Female
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
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
70
1st name | |
Middle name | |
Last name | Akira Inoue |
Tohoku University School of Medicine
Department of Palliative Medicine
2-1, Seiryocho, Aobaku, Sendai
022-717-7366
akira.inoue.b2@tohoku.ac.jp
1st name | |
Middle name | |
Last name | Akira Inoue |
Tohoku University School of Medicine
Department of Palliative Medicine
2-1, Seiryocho, Aobaku, Sendai
022-717-7366
akira.inoue.b2@tohoku.ac.jp
North-East Japan Study Group
North-East Japan Study Group
Other
NO
2016 | Year | 07 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 05 | Month | 25 | Day |
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 05 | Month | 25 | Day |
2018 | Year | 05 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025871
Research Plan | |
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Research case data | |
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