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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stomatitis
• Intervention / Treatment: Drug: Recombinant bovine basic fibroblast growth factor; Combination product: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recombinant bovine basic fibroblast growth factor	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.
Active Comparator: Quadruple mixture; Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade ≥ 3 mucositis	Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0	Day 56 after completion or termination of radiotherapy
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
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 21, 2018
• Primary Completion (Anticipated): December 20, 2019
• Study Completion (Anticipated): December 20, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Radiation therapy; Nasopharyngeal carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Anti-Infective Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Mitosis Modulators; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Micronutrients; Anti-Bacterial Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Protein Synthesis Inhibitors; Vitamins; Vitamin B Complex; Hematinics; Dexamethasone; Lidocaine; Gentamicins; Vitamin B 12; Hydroxocobalamin; Mitogens
• Other Study ID Numbers: HL003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No