Investigation of TJ-116 bukuryoingohangekobokuto for postoperative water brash in esophageal cancer.

JRCT ID: jRCTs021190001

Registered date:08/05/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 04/12/2020
• Target sample size: 24
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Symptoms of feeling, anxiety, water brash

Secondary Outcome

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, SMI, Grip strength,In Body Analysis, CONUT, nutrition-related markers)
7. Clinical examination

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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) or lactose intolerance
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

Related Information

• Primary Sponsor: Ishii Tadashi
• Secondary Sponsor: TSUMURA & CO.
• Secondary ID(s): UMIN000031003