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

Phase 2

Recruiting

• Conditions: Esophageal cancer; minimally invasive esophagectomy, enteral feeding

• Registration Number: JPRN-jRCTs051230110
• Lead Sponsor: Goto Hironobu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate adherence to dosing at 2 months after esophagectomy.

Secondary Outcome Measures

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