Feasibility study about supportive therapy with elemental diet, "elental", for chemotherapy induced oral mucositis in patients with gastorointestinal cancer.

Feasibility study about supportive therapy with elemental diet, "elental", for chemotherapy induced oral mucositis in patients with gastorointestinal cancer. - KSCOG CR-05

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016918

Enrollment

Registered

2015-03-26

Start date

2010-05-01

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

cancer chemotherapy induced oral mucositis

Interventions

Patients received the same chemotherapy regimen as during the previous treatment in addition received more than 80 g of elemental diet &quot

Elental&quot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with colorectal cancer experiencing stomatitis(grade 1-3 on CTC-AE ver3.0) after a course of FOLFOX or FOLFIRI based chemotherapy 1)age over 20 years and under 80 years 2)Performance status(ECOG) 0 - 2 3)life expetancy > 3months 4)without serious disorder in hematopoietic,hepatic and renal function 5)written informed consent

Exclusion criteria

Exclusion criteria: 1)cannot recovered from side effect of adjuvant chemotherapy 2)active infection 3)uncontrollable hypertention 4)uncontrollable diabete 5)clinically considerable cardiac disease 6)serious pulmonaly dissease 7)experience of clinically considerable psychological dysfunction or central nerve dysfunction 8)serious diarrhea 9)continuous systemic steroid treatment 10)pregnant women, nursing mother or women with childbearing intentions 11)participate in other clinical study 12)difficult to oral intake 13)physician judged inadequate for this study

Design outcomes

Primary

Measure	Time frame
improvement of oral mucositis	—

Secondary

Measure	Time frame
change of oral intake serological change frequency and degree of adverse event	—

Countries

Japan

Contacts

Public ContactYutaka Ogata

Kurume University Medical Center Department of surgery

yogata@med.kurume-u.ac.jp0942-22-6111

Outcome results

None listed

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

Feasibility study about supportive therapy with elemental diet, &quot;elental&quot;, for chemotherapy induced oral mucositis in patients with gastorointestinal cancer.