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Trial record 6 of 6 for:    "Nasopharyngeal Carcinoma" | "Dexamethasone acetate"

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

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ClinicalTrials.gov Identifier: NCT03778008
Recruitment Status : Not yet recruiting
First Posted : December 18, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Nanchang University

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.

Condition or disease Intervention/treatment Phase
Stomatitis Drug: Recombinant bovine basic fibroblast growth factor Combination Product: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis:An Open, Randomized, Controlled, Prospective Study
Estimated Study Start Date : December 21, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778008


Contacts
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Contact: long Huang, PhD 13699549060 ndefy13211@ncu.edu.cn

Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University

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Responsible Party: Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT03778008     History of Changes
Other Study ID Numbers: HL003
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital of Nanchang University:
Radiation therapy
Nasopharyngeal carcinoma
Additional relevant MeSH terms:
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Dexamethasone
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Gentamicins
Lidocaine
Mitogens
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors