Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer

Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer - Prophylactic effect of Elental on stomatitis in chemo(-radio)therapy for esophageal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007960

Enrollment

Registered

2012-05-15

Start date

2012-01-01

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

Elental Sodium gualenate hydrate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed esophageal cancer 2.over 20 and under 80 years of age 3. PS 0-2 4. No prior chemo(-radio)therapy within 6 months 5. Adequate oragn functions 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Active infection 2. Presence of ileus 3. Treatment with intravenous hyperalimentation 4. Receiving other enteral alimentation 5. Presence of uncorolled diabetes 6. Inappropriate cases

Design outcomes

Primary

Measure	Time frame
The grade of stomatitis by NCI-CTCAE ver. 4.0 Serum total protein, albimin, T-cholesterol, trigriceride, hemoglobin	—

Secondary

Measure	Time frame
QOL by EORTC-QLQ C30	—

Countries

Japan

Contacts

Public ContactTakeshi Ishikawa

Graduate School of Medical Science, Kyoto Prefectural University of Medicine Molecular Gastroenterology and Hepatology

iskw-t@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

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