A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis

Study Overview
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Brief Summary
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This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in China.

Official Title
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A Randomized, Multi-center, Single-use, Active-controlled, Open Study to Assess the Local Analgesic Effect of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis

Conditions
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Chemotherapy- and/or Radiation-induced Oral Mucositis

Intervention / Treatment
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* Device: episil®
* Device: Kang Su


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female patient 18 years of age; Pathological histologic and/or cytological diagnosis of malignant tumor; Patients who are suffering from symptomatic oral mucositis (WHO grade 2 or above) during chemotherapy and/or radiotherapy during screening period; Patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by Likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on Day 1; Patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on Day 1; Patients at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3; and Patients are able to provide written informed consent to participate in the study freely after the nature of the study and disclosure of data has been explained to the patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Device: episil®<br>* Firmly press the pump and apply the stream of liquid to the oral cavity 3 times (a total volume of 0.45 mL approximately). Distribute to affected areas in the mouth, for example by using the tongue. Wait for 5 minutes for the protective film to form.<br>|
| Active Comparator: Group B<br> | Device: Kang Su<br>* Gently pour 5 mL of rinse into the mouth, keep the rinse staying in the oral cavity for at least 1 minute, and spilt out the liquid.<br>* Other names: Generic of MuGard®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of pain score of oral mucositis | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). | During 6 hours after a single use of investigational medical device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity decrease inside the oral cavity | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). | During 6 hours after a single use of investigational medical device | 
| Peak pain intensity difference inside the oral cavity | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). | During 6 hours after a single use of investigational medical device | 
| Incidence of adverse events |  | 2 days |