UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients
Title of the study (Brief title)	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	Tadashi Ishii
Organization	Tohoku University Hospital
Division name	Department of Education and Support for Regional Medicine
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	Shin Takayama
Organization	Tohoku University Hospital
Division name	Department of Education and Support for Regional Medicine. Department of Kampo medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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