UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027561
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

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Basic information

Public title

Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery:a randomized, double-blind, placebo-controlled trial

Acronym

ProD Study

Scientific Title

Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery:a randomized, double-blind, placebo-controlled trial

Scientific Title:Acronym

ProD Study

Region

Japan


Condition

Condition

Preoperative anxiety and postoperative delirium

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Obstetrics and Gynecology Psychiatry Oto-rhino-laryngology
Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of Yokukansan on perioperative psychiatric symptoms in cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

1.Change in preoperative anxiety
2.Incidence rate of postoperative delirium

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

Placebo granules.
Oral administration of Placebo granules (7.5g/day t.i.d. before meals) for 4 days or over before operation

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.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

Key exclusion criteria

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

Target sample size

220


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Shimizu

Organization

National Cancer Center Hospital

Division name

Department of Psycho-oncology

Zip code


Address

5-1-1, Tsukiji Chuo-ku, Tokyo, 104-0045

TEL

03-3542-2511

Email

keshimiz@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Saho Wada

Organization

National Cancer Center Hospital

Division name

Department of Psycho-Oncology

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045

TEL

03-3542-2511

Homepage URL


Email

sawada@ncc.go.jp


Sponsor or person

Institute

National Cancer Center

Institute

Department

Personal name



Funding Source

Organization

TSUMURA & CO.

Organization

Division

Category of Funding Organization

Profit organization

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

国立がん研究センター中央病院(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 04 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

Completed

Date of protocol fixation

2017 Year 05 Month 19 Day

Date of IRB

2017 Year 07 Month 28 Day

Anticipated trial start date

2017 Year 08 Month 14 Day

Last follow-up date

2018 Year 08 Month 19 Day

Date of closure to data entry

2018 Year 10 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 12 Day

Date analysis concluded

2019 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 05 Month 31 Day

Last modified on

2019 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031488


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name