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

JRCT ID: jRCTs062220023

Registered date:30/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Squamous cell carcinoma, adenosquamous carcinoma, basal cell carcinoma
• Date of first enrollment: 30/05/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Use Epicil to prevent the onset of oral mucositis during neoadjuvant chemotherapy with DFP

Outcome(s)

• Primary Outcome: Severity 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
• Gender: Both

Include criteria

1.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 criteria

1.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

• Primary Sponsor: Takano HIdeyuki