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Prophylactic effect of Elental on stomatitis in chemotherapy with or without radiation for esophageal cancer

Prophylactic effect of Elental on stomatitis in chemotherapy with or without radiation for esophageal cancer - Prophylactic effect of Elental

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011956
Enrollment
84
Registered
2013-10-03
Start date
2012-08-04
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

Esophagealcancer

Interventions

Elental (1 pack per day) during radiation or chmeradiation No administration of Elental

Sponsors

Department of Gastroenterology, Toranomon Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed esophageal cancer 2.lesions located in the thoracic esophagus 3. M3 or deeper 4. No prior chemo(-radio)therapy 5. over 20 and under 80 years of age 6. PS 0-2 7. Adequate oragn functions 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. patients withe the past history of allergy to iodine 2. patients without cessation of anticoagulant therapy 3. Presence of other cancer 4. Pregnant or nursing women and those with the possibility of pregnancy 5. Mental or neurologic disease that might affect participation 6. Receiving steroid therapy 7. Positive HBs Antigen 8. Active infection 9. Presence of recent MI or history of unstable AP 10. Presence of uncorolled diabetes 11. Presence of uncontrolled hypertention 12. Presence of IP, pulmonary fibrosis, or severe CPE 13. patients with the past history of hypersensitivity to Elental 14. Abnormality in amino acid metabolism 15. patients considered inadequate for inclusion in this trial by the physician

Design outcomes

Primary

MeasureTime frame
Frequency or severity of oral erosion

Secondary

MeasureTime frame
1.Frequency of diarrhea, nausea or vomitting 2.Frequency of comlpetion of chemoradiotherapy of chemotherapy 3.decrease of Nutrition marker 4.loss of body weight 5.intake of Elental

Countries

Japan

Contacts

Public ContactToshiro Iizuka

Toranomon Hospital Department of Gastroenterology

t-iizuka@toranomon.gr.jp03-3588-1111

Outcome results

None listed

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