Phase II study on reduction of mucous membrane inflammation by the nutritional supplement Elental in concurrent chemoradiotherapy for head and neck squamous cell carcinoma

Phase II study on reduction of mucous membrane inflammation by the nutritional supplement Elental in concurrent chemoradiotherapy for head and neck squamous cell carcinoma - Reduction of mucous membrane inflammation by Elental in concurrent chemoradiotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010370

Enrollment

Registered

2013-04-01

Start date

2015-03-01

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

Head and neck cancer

Interventions

Elental (1 pack per day) from day 1 to 7 days after end of radiation therapy No administration of Elental

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical CCRT, ie, 3 courses of CDDP every 3 weeks plus whole-neck irradiation, including bilateral levels II-IV 2) Initial chemotherapy 3) Measurable or evaluable lesions 4) Performance status (PS) 0-1 5) Age 20-75 years 6) No complications that might affect treatment 7) No other cancer 8) Normal liver, kidney, and marrow function White blood cells >3,000/mm3 Neutrophils >1,500/mm3 Blood platelet >100,000mm3 Total bilirubin normal AST and ALT normal Creatinine normal Ccr or eGFR >60 ml/min 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Past history of serious drug hypersensitivity 2) Presence of other cancer 3) Clinically problematic infectious disease 4) >1 complication that might affect treatment 5) Nonradical treatment indicated 6) Pregnant or nursing women and those with the possibility of pregnancy 7) Mental or neurologic disease that might affect participation 8) Abnormality in amino acid metabolism 9) Severe diabetes or possibility of glucose metabolism abnormality due to high-dose steroid treatment 10) Participation judged by physician to be inadvisable

Design outcomes

Primary

Measure	Time frame
CTCAE score for inflammation of oral/pharyngeal mucosa	—

Secondary

Measure	Time frame
Rate of CCRT completion, duration of cessation of oral-intake, duration and dosage of opioids, days of Elental administration, days of hospitalization after CCRT, body weight, total protein, albumin decrease (%)	—

Countries

Japan

Contacts

Public ContactHiroshi Matsuyama

Niigata University, Faculty of Medicine Otolaryngology, Head and Neck

matsuhiroshi@med.niigata-u.ac.jp+81-25-227-2306

Outcome results

None listed

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