Unique ID issued by UMIN | UMIN000027561 |
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Receipt number | R000031488 |
Scientific Title | Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery:a randomized, double-blind, placebo-controlled trial |
Date of disclosure of the study information | 2017/06/04 |
Last modified on | 2019/04/23 09:12:25 |
Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery:a randomized, double-blind, placebo-controlled trial
ProD Study
Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery:a randomized, double-blind, placebo-controlled trial
ProD Study
Japan |
Preoperative anxiety and postoperative delirium
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Obstetrics and Gynecology | Psychiatry | Oto-rhino-laryngology |
Urology |
Malignancy
NO
To evaluate efficacy and safety of Yokukansan on perioperative psychiatric symptoms in cancer patients
Safety,Efficacy
Confirmatory
Explanatory
Phase III
1.Change in preoperative anxiety
2.Incidence rate of postoperative delirium
1.Severity of postoperative delirium (DRS-98-R)
2.Duration of postoperative delirium
3.Preoperative Benzodiazepine dose
4.Postoperative antipsychotic dose
5.Postoperative hospitalization days
6.Adverse events/reactions
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
TJ-54 TSUMURA Yokukansan Extract Granules for Ethical Use Oral administration of Yokukansan (7.5g/day t.i.d. before meals) for at least 4 days before operation.
Placebo granules.
Oral administration of Placebo granules (7.5g/day t.i.d. before meals) for 4 days or over before operation
20 | years-old | <= |
Not applicable |
Male and Female
1.Histological cancer diagnosis or clinical necessity undertaking neoplasm resection
2.Being scheduled to undergo highly invasive surgery.
3.Marking more than 1 point of Hospital Anxiety and Depression Scare-Anxiety (HADS-A) in registration
4.Feasibility of oral Yokukansan administration
5.Written informed consent to participate in this study
1.Drug abuse history including the stimulant drug
2.Delirium diagnosis with DSM-5 in registration
3.Kampo medication within 4 weeks ahead of registration
4.Medical history of serious drug allergy
5.Grade2 Hypokalemia or worse of CTCAE v4.0 within 8 weeks ahead of registration
6.Chemotherapy and/or radiotherapy planned within 1 week after surgery
7.Participation in other clinical trials, which use other medicine, within 3 months ahead of registration
8.Being judged as inadequate by physician
220
1st name | |
Middle name | |
Last name | Ken Shimizu |
National Cancer Center Hospital
Department of Psycho-oncology
5-1-1, Tsukiji Chuo-ku, Tokyo, 104-0045
03-3542-2511
keshimiz@ncc.go.jp
1st name | |
Middle name | |
Last name | Saho Wada |
National Cancer Center Hospital
Department of Psycho-Oncology
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045
03-3542-2511
sawada@ncc.go.jp
National Cancer Center
TSUMURA & CO.
Profit organization
NO
国立がん研究センター中央病院(東京都)
2017 | Year | 06 | Month | 04 | Day |
Unpublished
Completed
2017 | Year | 05 | Month | 19 | Day |
2017 | Year | 07 | Month | 28 | Day |
2017 | Year | 08 | Month | 14 | Day |
2018 | Year | 08 | Month | 19 | Day |
2018 | Year | 10 | Month | 31 | Day |
2018 | Year | 12 | Month | 12 | Day |
2019 | Year | 04 | Month | 30 | Day |
2017 | Year | 05 | Month | 31 | Day |
2019 | Year | 04 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031488
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