An Exploratory Clinical Trial on the Safety of Enteral Nutrition for Postoperative Esophageal Cancer Patients

JRCT ID: jRCTs051230110

Registered date:10/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 10/10/2023
• Target sample size: 32
• Study type: Interventional
• Intervention(s): In this study, enteral nutrition intervention will be performed in patients who have undergone minimally invasive esophagectomy, and enteral feeding tube placement.

Outcome(s)

• Primary Outcome: Evaluate adherence to dosing at 2 months after esophagectomy.

Secondary Outcome

Duration of Hinex-Egel administration
ECOG-PS (2 months, 3 months, 6 months after surgery)
Nutritional index items by blood biochemical tests (preoperative, 2 months, 3 months, and 6 months postoperatively)
Body weight loss rate at 2, 3, and 6 months after esophagectomy
Fat mass and skeletal muscle mass using CT images (preoperatively and 6 months postoperatively)
Measurement of body composition and muscle mass using bioelectrical impedance analysis (BIA)
Occurrence of disease, etc. (gastrointestinal symptoms related to protocol treatment: diarrhea, constipation, vomiting, etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Age 18 years or older at the time of consent
(2) Diagnosed as cStage I/II/III (12th edition of the Esophageal Cancer Treatment Protocol) and underwent subtotal esophagectomy, primary reconstruction, enteral tube placement
(3) ECOG-PS 0-2
(4) Able to take oral intake before surgery
(5) Expected to undergo surgery within 60 days of study enrollment (within 60 days of completion of chemotherapy for patients undergoing preoperative chemotherapy)
(6) Patients are expected to be able to take oral intake for 3 months after surgery
(7) The patient's free written consent to participate in the study has been obtained.

Exclude criteria

(1) The subject is allergic to oral nutritional supplements.
(2)Identified as allergic to any of the ingredients (especially soy and gelatin) in the test nutritional product, Hinex E-Gel LC.
(3) The subject has difficulty obtaining consent due to dementia or mental illness requiring treatment.
(4) The patient is taking steroids or immunosuppressive drugs due to an autoimmune disease, etc.
(5) Complicated viral infection requiring treatment.
(6) Other conditions deemed inappropriate by the Principal Investigator or Principal Investigators.

Related Information

• Primary Sponsor: Goto Hironobu