Unique ID issued by UMIN | UMIN000042360 |
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Receipt number | R000048357 |
Scientific Title | Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma |
Date of disclosure of the study information | 2020/11/05 |
Last modified on | 2023/10/18 14:09:09 |
Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
PROACT study
Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
PROACT study
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and safety of olanzapine for cisplatin-induced nausea and vomiting in patients with hepatocellular carcinoma treated with hepatic arterial infusion chemotherapy.
Safety,Efficacy
Confirmatory
Phase II
Complete response (CR) rate within 120 hours in patients treated with olanzapine
1) CR rate, complete control (CC) rate and total control (TC) rate within 24 hours
2) CR rate, CC rate and TC rate within 24-120 hours
3) Numerical rating scale scores of nausea, vomiting and anorexia on day 1-6
4) Frequency of vomiting within 120 hours
5) Frequency of rescue antiemetic treatment within 120 hours
6) Frequency, severity and timing of adverse events due to antiemetic treatment
7) Child-Pugh score and ALBI score at 2 weeks and 1 month after treatment
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
4
Treatment
Medicine |
<Initial treatment(1)>
Granisetron (GRA) 3mg, just before treatment
Olanzapine (OLA) 5mg, in the morning on day 1 and before bedtime on day 1-4
<Initial treatment(2)>
GRA 3mg, just before treatment
<Second treatment(1)>
In addition to initial treatment,
aprepitant (APR) 125mg, in the morning on day 1
APR 80mg, in the morning on day 2, 3
<Second treatment(2)>
Same as initial treatment
20 | years-old | <= |
Not applicable |
Male and Female
1) 20 years old or more
2) diagnosed of HCC according to the JSH guideline (2017)
3) CDDP-HAIC planned within 7 days
4) no prior HAIC within 3 months
5) informed consent obtained
1) pregnant, possibly pregnant or breastfeeding
2) regular use of olanzapine or other antipsychotic drugs
3) previous participation in this study
4) moderate or severe (NRS 4 or more) nausea
5) considered not appropriate for participating in this study
50
1st name | Masayuki |
Middle name | |
Last name | Ueno |
Kurashiki Central Hospital
Department of Gastroenterology and Hepatology
710-8602
1-1-1 Miwa, Kurashiki, Okayama, Japan
086-422-0210
mu13951@kchnet.or.jp
1st name | Masayuki |
Middle name | |
Last name | Ueno |
Kurashiki Central Hospital
Department of Gastroenterology and Hepatology
710-8602
1-1-1 Miwa, Kurashiki, Okayama, Japan
0864220210
mu13951@kchnet.or.jp
Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
No funding source
Other
Medical Ethics Committee, Kurashiki Central Hospital
1-1-1 Miwa, Kurashiki, Okayama, Japan
086-422-0210
kenkyu@kchnet.or.jp
NO
2020 | Year | 11 | Month | 05 | Day |
Unpublished
Completed
2020 | Year | 10 | Month | 14 | Day |
2020 | Year | 11 | Month | 04 | Day |
2020 | Year | 11 | Month | 05 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 09 | Month | 30 | Day |
2020 | Year | 11 | Month | 05 | Day |
2023 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048357
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