Clinical trial NCT03778008: Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis
Official title: Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis：An Open, Randomized, Controlled, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomatitis
Keywords: Radiation therapy
Nasopharyngeal carcinoma
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the risk of infection and may affect clinical outcomes due to treatment interruption, dose reduction, and reduced treatment compliance. In China, a quadruple mixture of dexamethasone, gentamicin, vitamin B12, and lidocaine is commonly used in patients who begin to have radiation-induced oral mucositis . However, the incidence of radiation-induced oral mucositis remains high. Recombinant bovine basic fibroblast growth factor is a multifunctional cell growth factor that stimulates the growth of cells derived from mesoderm and neuroectodermal cells and thus has a wide range of biological activities. The drug has different degrees of promotion on the three stages of the wound repair process, namely the local inflammatory reaction stage, cell proliferation and differentiation, granulation tissue formation stage and tissue reconstruction stage. The purpose of this randomized controlled trial was to evaluate the efficacy of recombinant bovine basic fibroblast growth factor as an intervention in radiation-induced oral mucositis for the treatment of nasopharyngeal carcinoma , with a commonly used quadruple mixture (from dexamethasone, gentamicin , vitamin B12 and lidocaine composition) were compared.


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed and previously untreated nasopharyngeal carcinoma
2. Age ≥ 18 years and ≤ 65 years.
3. Karnofsky performance status (KPS) score ≥ 70
4. Planned to receive radiotherapy alone or concurrent chemoradiotherapy
5. Adequate bone marrow function: while blood cell \>= 3,000/μL, absolute neutrophil count \>= 1,500/μL, hemoglobin \>= 100g/L, platelet \>= 75,000/μL.
6. Life expectancy of \>= 3 months.

Exclusion Criteria:

1. Younger than 18 years old or older than 70 years old
2. Pregnancy or lactation
3. Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
4. Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
5. Refuse to give up smoking/drinking/betel chewing
6. suffering from other active infection diseases and in need of treatment.
7. 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.

Primary outcomes:
measure: Incidence of grade ≥ 3 mucositis
timeFrame: Day 56 after completion or termination of radiotherapy
measure: EORTC QLQ-C30
timeFrame: Day 56 after completion or termination of radiotherapy
measure: WHO score
timeFrame: Day 56 after completion or termination of radiotherapy
measure: OMDQ MTS question 2 (Q2) score
timeFrame: Day 56 after completion or termination of radiotherapy
measure: OMAS
timeFrame: Day 56 after completion or termination of radiotherapy
Secondary outcomes:
Other outcomes:
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