NIPH Clinical Trials Search

JRCT ID: jRCTs062220023

Registered date:30/05/2022

Evaluation of the efficacy of bioadhesive barrier-forming oral liquid gel (Episil) for prevention of oral mucositis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSquamous cell carcinoma, adenosquamous carcinoma, basal cell carcinoma
Date of first enrollment30/05/2022
Target sample size50
Countries of recruitment
Study typeInterventional
Intervention(s)Use Epicil to prevent the onset of oral mucositis during neoadjuvant chemotherapy with DFP


Primary OutcomeSeverity assessment of oral mucositis by CTCAC v3.0
Secondary Outcome(1) Severity evaluation of oral mucositis by CTCAE v4.0 (2) Evaluation of pain by Numerical Rating Scale (NRS) (3) Incidence of oral mucositis

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 100age old
Include criteria1.Patients who are histologically diagnosed as squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma by endoscopic biopsy of the primary esophageal lesion 2.Patients whose treatment policy in esophageal surgery is preoperative chemotherapy with DFP and surgery 3.Patients whose Performance status (PS) is 0, 1 or 2 according to ECOG criteria 4.Patients who have written consent to participate in the study
Exclude criteria1.Patients with cancer lesions in the oral cavity 2.Patients with obvious wounds in the oral cavity other than oral mucositis 3.Patients known to be allergic to the components of Epicil 4.Patients participating in other clinical trials or clinical studies 5.Female patients who are breastfeeding, pregnant, or may become pregnant 6.In addition, patients who find it difficult to carry out this study at the discretion of the researcher

Related Information


Public contact
Address 3-18-15 Kuramoto, Tokushima 770-8503, Japan Tokushima Japan 7708007
Telephone +81-88-633-7352
Affiliation Tokushima University Hospital
Scientific contact
Name HIdeyuki Takano
Address 3-18-15 Kuramoto, Tokushima 770-8503, Japan Tokushima Japan 770-8504
Telephone +81-88-633-7352
Affiliation Tokushima University Hospital