Intervention study using K15 lactic acid bacteria for patients with esophageal cancer

JRCT ID: jRCTs051210002

Registered date:05/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 08/06/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): 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).

Outcome(s)

• Primary Outcome: Incidence of oral mucositis during chemotherapy (CTCAE ver.5 grade2 or higher)

Secondary Outcome

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.)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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).

Exclude 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

Related Information

• Primary Sponsor: Miyata Hiroshi
• Source(s) of Monetary Support: Kikkoman Corporation