JPRN-jRCTs051210002
Recruiting
Phase 2
Examination of the adverse event occurrence suppression effect by K15 lactic acid bacteria intake during preoperative chemotherapy for esophageal cancer - K15 lactic acid bacteria for esophageal cancer
Miyata Hiroshi0 sites50 target enrollmentApril 5, 2021
ConditionsEsophageal cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Esophageal cancer
- Sponsor
- Miyata Hiroshi
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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
Outcomes
Primary Outcomes
Not specified
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