Unique ID issued by UMIN | UMIN000010818 |
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Receipt number | R000012664 |
Scientific Title | Evaluation of combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-emetic-risk chemotherapy in patients. |
Date of disclosure of the study information | 2013/05/28 |
Last modified on | 2018/06/04 10:45:35 |
Evaluation of combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-emetic-risk chemotherapy in patients.
PROEMEND
Evaluation of combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-emetic-risk chemotherapy in patients.
PROEMEND
Japan |
Patient who has high-emetic-risk chemotherapy as first-ilne
Gastroenterology |
Malignancy
NO
To evaluate combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-risk-chemotherapy in patients.
Safety,Efficacy
Not applicable
*Severity of nausea
*Severity of nausea
*Grading of appetite
*Used amount of per-request medication
*weariness
*hiccough
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
Group A:
*1st course: Conventional therapy (Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
* 2nd course: Conventional therapy ((Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
Group B:
* 1st course: Conventional therapy (Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
* 2nd course: Conventional therapy ((Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
20 | years-old | <= |
Not applicable |
Male and Female
(1)Patients who has high-emetic-risk chemotherapy as first line.
(2)Performance Status (ECOG)=0-2
(1)Patients during pimozide administration
(2)Patients who has severe liver failure or renal failure
(3)Patients who enforced high- or moderate-emetic-risk chemotherapy in the past
(4)Patients who has vomited or provoed nausea in the 24 hours prior to start of chemotherapy
(5)Patients who is considered inappropriate as a target patient by a physician-in-charge
200
1st name | |
Middle name | |
Last name | Masashiro Goto |
Osaka Medical College Hospital
Chemotherapy Center
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
072-683-1221
in2030@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Masahiro Goto |
Osaka Medical College Hospital
Chemotherapy Cancter
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
072-683-1221
in2030@poh.osaka-med.ac.jp
Osaka Medical College Hospital
Osaka Medical College Hospital
Self funding
Japan
NO
大阪医科大学附属病院(大阪府)
Osaka Medical College Hospital(Osaka Prefecture)
2013 | Year | 05 | Month | 28 | Day |
Unpublished
No longer recruiting
2012 | Year | 12 | Month | 17 | Day |
2012 | Year | 12 | Month | 17 | Day |
2015 | Year | 12 | Month | 17 | Day |
2013 | Year | 05 | Month | 28 | Day |
2018 | Year | 06 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012664
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