StomatitisPhase 2NCT03778008
Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis
A Phase 2 study testing Recombinant bovine basic fibroblast growth factor and Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition in people with Stomatitis, run by Second Affiliated Hospital of Nanchang University.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stomatitis
- What is being tested?
- Recombinant bovine basic fibroblast growth factor and Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2018to 20 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Stomatitis
- Being tested
- Recombinant bovine basic fibroblast growth factor, Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
- Keywords
- Radiation therapy, Nasopharyngeal carcinoma
- Medical subject headings
- Stomatitis, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant bovine basic fibroblast growth factorDrug
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.
Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine compositionCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant bovine basic fibroblast growth factor | Experimental | Not described Receives: Drug: Recombinant bovine basic fibroblast growth factor |
| Quadruple mixture | Active comparator | Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition Receives: Combination Product: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥ 3 mucositis
Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 56 after completion or termination of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start21 Dec 2018 (estimated)
- Primary completion20 Dec 2019 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778008
- Sponsor's protocol ID
- HL003
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis：An Open, Randomized, Controlled, Prospective Study
- ClinicalTrials.gov ID
- NCT03778008
- Acronym / sponsor ID
- HL003
- Conditions
- Stomatitis
- Keywords
- Radiation therapy, Nasopharyngeal carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 21 Dec 2018 (estimated)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant bovine basic fibroblast growth factor | Experimental | Drug: Recombinant bovine basic fibroblast growth factor |
| Quadruple mixture | Active comparator | Combination Product: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine compositionQuadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant bovine basic fibroblast growth factorRecombinant 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. | Drug | Recombinant bovine basic fibroblast growth factor |
| Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine compositionQuadruple 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. | Combination product | Quadruple mixture |
Primary outcome
Incidence of grade ≥ 3 mucositis
Time frame: Day 56 after completion or termination of radiotherapy
Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0
EORTC QLQ-C30
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant bovine basic fibroblast growth factor and Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition in people with Stomatitis, run by Second Affiliated Hospital of Nanchang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact long Huang, PhD (13699549060, ndefy13211@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥ 3 mucositis (time frame: Day 56 after completion or termination of radiotherapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.