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 2

• Conditions: Head and neck cancer

• Registration Number: JPRN-UMIN000010370
• Lead Sponsor: iigata University, Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-01
• Study Completion: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CTCAE score for inflammation of oral/pharyngeal mucosa

Secondary Outcome Measures

Name	Time	Method
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 (%)