Esophageal cancer Esophageal cancer, sinbiotics
Conditions
Interventions
Synbiotics are administered orally or enterally during the perioperative period for esophageal cancer.
Synprotech consists of probiotics (Lactic acid bacteria Shirota strain, Bifidobacterium BY strain
Sponsors
Inoue Seiya
Takizawa Hiromitsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20 years or older (regardless of gender) 2) cStage II and III advanced esophageal cancer (regardless of histological type) 3) No obvious distant metastasis 4) Sufficient explanation regarding participation in this study was given to the participant before the start of the study, and written informed consent was obtained from the participant.
Exclusion criteria
Exclusion criteria: 1) If an adverse event occurs that makes it difficult to continue administering the study drug, and the principal investigator or sub-study physician deems it necessary to discontinue the study. 2) When a request for discontinuation is received from the subject or his/her legal guardian. 3) Cases with infectious enteritis or inflammatory bowel disease 4) Cases with serious liver disease 5) Cases with serious kidney disease 6) Breastfeeding/pregnant women or cases with high possibility of pregnancy 7) Cases participating in or willing to participate in other clinical studies 8) Cases with allergic reactions to dairy products 9) In other cases where the study director or study sub-study physician determines that it is impossible for the subject to continue the study. 10) If the person supervising the study or the principal investigator makes a decision to discontinue the study. When a study is discontinued, the "date of discontinuation" is not the date on which the event that caused the discontinuation occurred, but the date on which the principal investigator or sub-study physician decides to discontinue. However, 2) shall be the date on which the request is made by the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events of preoperative chemotherapy and incidence of postoperative complications Perioperative nutritional evaluation using nutritional indicators | — |
Secondary
| Measure | Time frame |
|---|---|
| Discontinuation of preoperative chemotherapy, relative volume intensity (RDI) Postoperative gas, defecation start date, existence and frequency of diarrhea after tube feeding and oral intake, time to start eating, number of days until complete porridge, weight change, length of hospital stay Disease-free survival rate (DFS) | — |
Contacts
Public ContactSeiya Inoue
Tokushima Unicersity Hospital
Outcome results
None listed