Clinical trial NCT03546985: A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy- and/or Radiation-induced Oral Mucositis
Lead sponsor: Solasia Pharma K.K.
Sponsor class: INDUSTRY
Collaborators: name: Solasia Medical Information Consulting (Shanghai) Co. Ltd.
First posted: 2018-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the curve (AUC) of pain score of oral mucositis
timeFrame: During 6 hours after a single use of investigational medical device
Secondary outcomes:
measure: Pain intensity decrease inside the oral cavity
timeFrame: During 6 hours after a single use of investigational medical device
measure: Peak pain intensity difference inside the oral cavity
timeFrame: During 6 hours after a single use of investigational medical device
measure: Incidence of adverse events
timeFrame: 2 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: The People's Liberation Army 307 Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The People's Liberation Army 81 Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Jiangsu People's Hospital
name: Xinchen Sun
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Guoyao Tang
role: PRINCIPAL_INVESTIGATOR
References: