UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031330 |
|---|---|
| Receipt number | 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 10:00:20 |
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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
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
takayama@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Education and Support for Regional Medicine.
Department of Kampo medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035757
