Stomatitis
Conditions
Brief summary
The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy
Detailed description
Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.
Interventions
DRUGrhEGF
rhEGF 50 μg/ml, spray type, twice a day
DRUGPlacebo
Placebo, Spray type, Twice a day
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, aged at least 18 years
Exclusion criteria
* Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential * Have oral mucositis or other oral conditions at study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe oral mucositis (RTOG garde 3 or 4) | 5 weeks(at the point of receiving 50 Gy radiation) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis | 5 weeks(at the point of receiving 50 Gy radiation) |
| Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis | 5 weeks(at the point of receiving 50 Gy radiation) |
Countries
South Korea
Outcome results
None listed