Status:
UNKNOWN
Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis
Lead Sponsor:
Second Affiliated Hospital of Nanchang University
Conditions:
Stomatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Radiation therapy is one of the treatments for Nasopharyngeal carcinoma . The most common side effects of post-radiation may be radiation-induced oral mucositis . When severe, oral mucositis increases...
Eligibility Criteria
Inclusion
- Pathologically confirmed and previously untreated nasopharyngeal carcinoma
- Age ≥ 18 years and ≤ 65 years.
- Karnofsky performance status (KPS) score ≥ 70
- Planned to receive radiotherapy alone or concurrent chemoradiotherapy
- Adequate bone marrow function: while blood cell \>= 3,000/μL, absolute neutrophil count \>= 1,500/μL, hemoglobin \>= 100g/L, platelet \>= 75,000/μL.
- Life expectancy of \>= 3 months.
Exclusion
- Younger than 18 years old or older than 70 years old
- Pregnancy or lactation
- Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
- Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
- Refuse to give up smoking/drinking/betel chewing
- suffering from other active infection diseases and in need of treatment.
- Known allergic reaction to any component of Recombinant Bovine Basic Fibroblast Growth Factoor or quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and lidocaine, or severe allergic constitution.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03778008
Start Date
December 21 2018
End Date
December 20 2019
Last Update
December 27 2018
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