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

Stomatitis Clinical Trial

Official title:

Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis：An Open, Randomized, Controlled, Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03778008
• Other study ID #: HL003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 21, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2018
• Source: Second Affiliated Hospital of Nanchang University
• Contact: long Huang, PhD
• Phone: 13699549060
• Email: ndefy13211[@]ncu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Stomatitis

Intervention

Drug:
• Recombinant bovine basic fibroblast growth factor
Recombinant bovine basic fibroblast growth factor is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of recombinant bovine basic fibroblast growth factor at the onset of radiotherapy, four times a day (after meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.

Combination Product:
• Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
Quadruple mixture is prescribed at the beginning of radiotherapy. Patients are asked to start application of quadruple mixture at the onset of radiotherapy, four times a day (before meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade = 3 mucositis	Incidence of grade = 3 mucositis according to CTCAE version 5.0	Day 56 after completion or termination of radiotherapy
Primary	EORTC QLQ-C30	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.	Day 56 after completion or termination of radiotherapy
Primary	WHO score	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).	Day 56 after completion or termination of radiotherapy
Primary	OMDQ MTS question 2 (Q2) score	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.	Day 56 after completion or termination of radiotherapy
Primary	OMAS	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.	Day 56 after completion or termination of radiotherapy