UMIN-CTR Clinical Trial

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 Obsterics 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
Last 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
1st 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
Institute	National Cancer Center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031488