Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT

NCT02735317 | Unknown Phase 2

• 1 other identifier: B2015-074-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy. When severe, oral mucositis increases the risk of infection and may compromise clinical outcomes by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. In China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine, is commonly prescribed when NPC patients begin to suffer from radiation-induced OM. However, the incidence of radiation-induced OM is still quite high. Oral Ulcer Gargle (FORRAD®) is a proprietary viscous liquid mucoadhesive hydrogel formulation. It creates a palliative barrier over injured mucosa, to prevent and to cure radiation-induced OM. The objective of this randomized phase II study is to assess the efficacy and safety of Oral Ulcer Gargle (FORRAD®) as an intervention for radiation-induced OM in the treatment of NPC, compared with the commonly used quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine.

Conditions

Nasopharyngeal Neoplasms; Stomatitis

Keywords

Nasopharyngeal carcinoma (NPC); radiotherapy; oral mucositis (OM)

Outcome Measures

Primary Outcomes (5)

• Incidence of grade ≥ 3 mucositis

  Incidence of grade ≥ 3 mucositis according to CTCAE version 4.0

  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

• 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

• 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

• 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

Secondary Outcomes (5)

• Interruption time during the schedule of radiotherapy

  Through radiotherapy completion or termination, an average of 7 weeks

• Time for healing of radiation-induced oral mucositis

  Through study completion, an average of 15 weeks

• The cumulative dose of opioid used

  Through study completion, an average of 15 weeks

• The cumulative time using opioid

  Through study completion, an average of 15 weeks

• The change of body weight from baseline.

  Baseline and 7 weeks

Study Arms (2)

FORRAD group

EXPERIMENTAL

This group of patients will receive Oral Ulcer Gargle (FORRAD®) during study for prevention and treatment of acute radiation-induced oral mucositis (OM). This is the experimental group.

Drug: Oral Ulcer Gargle (FORRAD®)

Quadruple mixture group

ACTIVE COMPARATOR

This group of patients will receive quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine, during study for prevention and treatment of acute radiation-induced oral mucositis (OM). This is the active comparator group.

Drug: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine

Interventions

Oral Ulcer Gargle (FORRAD®) DRUG

Oral Ulcer Gargle (FORRAD®) is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of Oral Ulcer Gargle (FORRAD®) 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.

FORRAD group

Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine DRUG

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.

Quadruple mixture group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, with intensity-modulated radiation therapy (IMRT).
• 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.

You may not qualify if:

• Known allergic reaction to any component of Oral Ulcer Gargle (FORRAD®) or quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine, or severe allergic constitution.
• Other conditions that the investigators consider as inappropriate for enrolling into this study.

Sponsors & Collaborators

• Yun-fei Xia: lead

Study Sites (1)

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

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MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Stomatitis; Nasopharyngeal Carcinoma

Interventions

Gentamicins; Vitamin B 12; Procaine

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Yun-fei Xia, M.D.

CONTACT

+86-20-87343096; xiayf@sysucc.org.cn

Wenwen Zhang, M.D.

CONTACT

+86-20-87343096; zhangww@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Department of Radiation Oncology

Study Record Dates

• First Submitted: March 27, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

CN (1)