Esophageal cancer
Conditions
Interventions
K15 Lactobacillus preparation (10mg) will be taken every day from the time when consent is obtained (before chemotherapy administration) to the end of chemotherapy (day 14).
Sponsors
Miyata Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Endoscopic biopsy confirmed histologically to be esophageal cancer (regardless of tissue type). (2) Patients with resectable esophageal cancer that does not show metastases to other organs by pre-treatment imaging and who are scheduled to undergo radical surgery for esophageal cancer after preoperative chemotherapy. (3) Dysphagia score 0-2 (4) Age: 20 to 80 years old (5) ECOG Performance status: 0-1 (6) Patients whose functions of major organs (bone marrow, heart, lungs, kidneys, etc.) are well preserved. (7) Cases where written consent was obtained from the patient (8) It can be judged that esophagectomy can be performed by thoracotomy (or thoracoscopic) laparotomy (or laparoscopic).
Exclusion criteria
Exclusion criteria: (1) Active double cancer (excluding double cancer that can be cured by local treatment) (2) Cases with a history of irradiation for head and neck cancer (3) Cases with severe absorption disorders (4) Patients with severe passage obstruction who require central parenteral nutrition or nutritional support with nasogastric tube during registration (5) Cases in which the dose of the initial preoperative chemotherapy needs to be reduced due to decreased organ function or failure (6) Cases of inflammatory bowel disease (7) Patients with poor glycemic control during treatment (HbA1c>8.0%) (8) Cases with milk protein allergy (9) Cases with a history of gastrointestinal resection (10) Cases that the investigator considers inappropriate (11) Patients with severe mental disorders who cannot understand the contents of the test (12) Patients currently undergoing or having a history of diagnosis of xerostomia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of oral mucositis during chemotherapy (CTCAE ver.5 grade2 or higher) | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral mucositis incidence(CTCAE ver.3 grade 3 or higher) Adverse events until the end of chemotherapy Lymphocyte reduction, neutropenia, lymphopenia, thrombocytopenia Hepatic dysfunction, renal dysfunction, diarrhea, vomiting, febrile neutropenia Changes in taste due to chemotherapy and taste disorders and observation findings of the tongue papilla Indicators related to oral environment sIgA, sIgG, sIgM in saliva Oral microbiota analysis (metagenomic analysis) Nutritional indicators ( Body weight, total protein, albumin,etc) Tolerability of chemotherapy Effect of chemotherapy, completion rate of chemotherapy, discontinuation, suspension, weight reduction,Drugs used to prevent adverse events Perioperative complications(Pneumonia, suture failure, empyema, intraabdominal abscess, wound infection, etc.) | — |
Contacts
Public ContactTakashi Kanemura
Osaka International Cancer Institute
Outcome results
None listed