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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027561
Receipt No. 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

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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
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
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
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/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


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