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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031330
Receipt No. R000035757
Scientific Title Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients
Date of disclosure of the study information 2018/02/16
Last modified on 2018/02/16

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Basic information
Public title Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients
Acronym Investigation of TJ-116 bukuryoingohangekobokuto for postoperative water brash in esophageal cancer.
Scientific Title Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients
Scientific Title:Acronym Investigation of TJ-116 bukuryoingohangekobokuto for postoperative water brash in esophageal cancer.
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In order to examine the effectiveness and safety of TJ-116 Tsumura bukuryoingohangekobokuto for anxiety accompanying esophageal cancer and postoperative water brash, Hospital Anxiety and Depression Scale: HADS, Assessment of Swallowing Ability for Pneumonia: ASAP, Esophagus and Stomach Surgery Symptom Scale: ES4, and Videofluoroscopic examination of swallowing: VF were measured as main evaluation items.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Symptoms of feeling, anxiety, water brash
Key secondary outcomes 1. Incidence frequency of aspiration pneumonia
2. Postoperative hospital stay
3. Abdominal gas volume
4. Inflammatory marker (IL-6,TNFa,G-CSF,WBC)
5. Chest CT
6. Nutritional status (Body weight, BMI, TSF, AMC, Grip strength,In Body Analysis, CONUT, nutrition-related markers)
7. Clinical examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Conventional treatment
Interventions/Control_2 In addition to conventional treatment, bukuryoingohangekobokuto is divided into 3 times 7.5 g per day (2.5 g (1 package) once a day), from 2 weeks before operation to 6 weeks after operation or until discontinuation (surgery Except that day) before meals are administered orally in principle.
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. Patients waiting for chest upper to lower
esophageal cancer radical resection
2. Pre treatment cStage:II, III, IVA (except for T4b, N3) TNM classification:T=1-4a, N=0-2, M=0(TNM-UICC 8 th edition)
3. Performance Status:0-2
4. Hospital Anxiety and Depression Scale (HADS): 8 <=
5. 20 years old and over
6. Medical examination classification:outpatient and inpatient
7. Patients who obtain document consent from the principal
Key exclusion criteria 1. Patients who have past history of abdominal surgery
2 Patients who have past history of ileus
3 Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease
4. Eemergent surgery
5. Patients who took prohibited concomitant drugs 4 weeks before treatment
6. Patients who have past history of radiotherapy and radiation chemotherapy for esophageal cancer
7. Patients who have past history of allergy for other Kampo formulation(s)
8. Patients who have serious concomitant diseases
9. A woman who is pregnant, has a possibility of pregnancy, is within 28 days after birth, is breastfeeding
10. Dementia patients
11. Others, including patients who are unfit for the study as determined by the attending physician
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Ishii
Organization Tohoku University Hospital
Division name Department of Education and Support for Regional Medicine
Zip code
Address 1-1, seiryomachi, aobaku, sendai city, miyagi prefecture, Japan
TEL 022-717-7587
Email t-ishi23@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin Takayama
Organization Tohoku University Hospital
Division name Department of Education and Support for Regional Medicine. Department of Kampo medicine
Zip code
Address 1-1, seiryomachi, aobaku, sendai city, miyagi prefecture, Japan
TEL 022-717-7507
Homepage URL
Email takayama@med.tohoku.ac.jp

Sponsor
Institute Department of Education and Support for Regional Medicine.
Department of Kampo medicine
Institute
Department

Funding Source
Organization TSUMUA & 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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 16 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 16 Day
Last modified on
2018 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035757

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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