Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis
Primary Purpose
Stomatitis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Recombinant bovine basic fibroblast growth factor
Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
Sponsored by
About this trial
This is an interventional treatment trial for Stomatitis focused on measuring Radiation therapy, Nasopharyngeal carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Recombinant bovine basic fibroblast growth factor
Quadruple mixture
Arm Description
Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
Outcomes
Primary Outcome Measures
Incidence of grade ≥ 3 mucositis
Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0
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.
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).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03778008
First Posted
December 10, 2018
Last Updated
December 26, 2018
Sponsor
Second Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT03778008
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2018 (Anticipated)
Primary Completion Date
December 20, 2019 (Anticipated)
Study Completion Date
December 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomatitis
Keywords
Radiation therapy, Nasopharyngeal carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recombinant bovine basic fibroblast growth factor
Arm Type
Experimental
Arm Title
Quadruple mixture
Arm Type
Active Comparator
Arm Description
Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
Intervention Type
Drug
Intervention Name(s)
Recombinant bovine basic fibroblast growth factor
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of grade ≥ 3 mucositis
Description
Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0
Time Frame
Day 56 after completion or termination of radiotherapy
Title
EORTC QLQ-C30
Description
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.
Time Frame
Day 56 after completion or termination of radiotherapy
Title
WHO score
Description
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).
Time Frame
Day 56 after completion or termination of radiotherapy
Title
OMDQ MTS question 2 (Q2) score
Description
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.
Time Frame
Day 56 after completion or termination of radiotherapy
Title
OMAS
Description
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.
Time Frame
Day 56 after completion or termination of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
long Huang, PhD
Phone
13699549060
Email
ndefy13211@ncu.edu.cn
12. IPD Sharing Statement
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Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis
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