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

Phase II Study to evaluate the efficacy and safety of bioadhesive barrier-forming oral liquid gel (Episil) for prevention of oral mucositis in patients who are receiving chemotherapy (In DFP therapy of esophageal cancer)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062220023
Enrollment
50
Registered
2022-05-30
Start date
2022-05-30
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

Squamous cell carcinoma, adenosquamous carcinoma, basal cell carcinoma

Interventions

Use Epicil to prevent the onset of oral mucositis during neoadjuvant chemotherapy with DFP

Sponsors

Momota Yukihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Severity assessment of oral mucositis by CTCAC v3.0

Secondary

MeasureTime frame
(1) Severity evaluation of oral mucositis by CTCAE v4.0 (2) Evaluation of pain by Numerical Rating Scale (NRS) (3) Incidence of oral mucositis

Contacts

Public ContactTAKANO HIDEYUKI

Tokushima University Hospital

takano@tokushima-u.ac.jp+81-88-633-7352

Outcome results

None listed

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