Usefulness of synbiotic administration in the perioperative period for esophageal cancer

JRCT ID: jRCTs061240012

Registered date:15/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 15/05/2024
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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), powder, prebiotics (galacto-oligosaccharide liquid sugar), and liquid, taken one packet three times a day. However, at the time of discharge from the hospital after surgery, it is determined that the intestinal flora has improved, and the patient will be given one packet once a day.
Administration will begin at the start of preoperative chemotherapy, continue during the drug withdrawal period from preoperative chemotherapy until surgery, and will be completed one year after surgery.

Outcome(s)

Primary Outcome

Incidence rate of adverse events of preoperative chemotherapy and incidence of postoperative complications
Perioperative nutritional evaluation using nutritional indicators

Secondary Outcome

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)

Key inclusion & exclusion criteria

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

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Inoue Seiya
• Secondary Sponsor: Takizawa Hiromitsu