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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
Second Affiliated Hospital of Nanchang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomatitis focused on measuring Radiation therapy, Nasopharyngeal carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    December 10, 2018
    Last Updated
    December 26, 2018
    Sponsor
    Second Affiliated Hospital of Nanchang University
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    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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