The Phase II study of ONS for preventing post-esophagectomy body weight loss in patients with thoracic esophageal cancer
Phase 2
- Conditions
- esophageal cancer
- Registration Number
- JPRN-UMIN000019086
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1)Comorbidities Confirmed or suspected infection. Diabetes. Unstable angina pectoris, or history of myocardial infarction within six months. Uncontrolable congestive heart failure and arrhythmia Severe psychiatric disease. Dialysis patient. Amino acid metabolic disorder. Pregnant or possibility of pregnancy. 2)medicine Continuous systemic steroid therapy. 3)Others Contraindication to Elental. Judged by the investigator to be inappropriate for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of the patients who represent weight loss more than 10% in the postoperative 12 weeks
- Secondary Outcome Measures
Name Time Method incidence and severity of adverse events, the rate of the patients who completed the course, The rate of skeletal muscle loss in postoperative 12 weeks, nutrition index (body weight, BMI, serum albumin level, serum total cholesterol level, total lymphocyte count), QOL score (EORTC QLQ-C30, OES18, DAUGS, EQ-5D-5L), Gait speed (usual and maximum), handgrip strength, arm circumference (cm), triceps skinfolds (cm), calf circumference (cm)