The Phase II study of ONS for preventing post-esophagectomy body weight loss in patients with thoracic esophageal cancer

The Phase II study of ONS for preventing post-esophagectomy body weight loss in patients with thoracic esophageal cancer - ONS for preventing post-esophagectomy body weight loss

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019086

Enrollment

Registered

2015-09-21

Start date

2015-06-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Take elental for 12 weeks after esophagectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma or basaloid carcinoma at endoscopic biopsy. 2)Primary tumor located at thoracic esophagus (UICC7th). 3)Either with or without neoadjuvant chemotherapy. 4)R0 esophagectomy is expected. 5)Aged 20 to 80 years. 6)PS (ECOG) of 0 or 1. 7)Adequate organ function. 8)Written informed consent from patient.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The rate of the patients who represent weight loss more than 10% in the postoperative 12 weeks	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactJiro Kawakami

Aichi Cancer Center Hospital Department of Gastroenterological Surgery

j.kawakami@aichi-cc.jp052-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026