Chemotherapy- and/or Radiation-induced Oral Mucositis
Conditions
Brief summary
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.
Interventions
DEVICEepisil®
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.
DEVICEKang Su
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.
Sponsors
Solasia Medical Information Consulting (Shanghai) Co. Ltd.
Solasia Pharma K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of pain score of oral mucositis | During 6 hours after a single use of investigational medical device | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity decrease inside the oral cavity | During 6 hours after a single use of investigational medical device | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). |
| Peak pain intensity difference inside the oral cavity | During 6 hours after a single use of investigational medical device | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). |
| Incidence of adverse events | 2 days | — |
Countries
China
Outcome results
None listed