Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis

Phase 2

• Conditions: Stomatitis
• Interventions: Combination Product: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition; Drug: Recombinant bovine basic fibroblast growth factor

• Registration Number: NCT03778008
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-19
• Study Start: 2018-12-21
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadruple mixture	Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition	Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
Recombinant bovine basic fibroblast growth factor	Recombinant bovine basic fibroblast growth factor	-

Primary Outcome Measures

Name	Time	Method
Incidence of grade ≥ 3 mucositis	Day 56 after completion or termination of radiotherapy	Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0
EORTC QLQ-C30	Day 56 after completion or termination of radiotherapy	EORTC QLQ-C30 is a Quality-of-Life Instrument proposed by the European Organization for Research and Treatment of Cancer (EORTC), for use in International Clinical Trials in Oncology. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.
WHO score	Day 56 after completion or termination of radiotherapy	The World Health Organization (WHO) Oral Toxicity score combines both elements into a single score that grades the severity of the condition from 0 (no oral mucositis) to 4 (swallowing not possible such that patient needs supplementary nutrition).
OMDQ MTS question 2 (Q2) score	Day 56 after completion or termination of radiotherapy	Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) is a 5-point categorical scale in which patients grade MTS from 0 (no soreness) to 4 (extreme soreness)3 which is a component of the OMDQ in that it tracks very well with objective (WHO score and opioid use) and subjective measurement of OM severity.
OMAS	Day 56 after completion or termination of radiotherapy	Oral Mucositis Assessment Scale (OMAS) provides an objective assessment of oral mucositis based on assessment of the appearance and extent of redness and ulceration in various areas of the mouth.