Clinical trial NCT02735317: Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT
Official title: Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT: A Single-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Stomatitis
Keywords: Nasopharyngeal carcinoma (NPC)
radiotherapy
oral mucositis (OM)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Nasopharyngeal carcinoma (NPC) is one of the most common malignances in South China. Radiation therapy remains the principal treatment for 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. Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays, the incidence of radiation-induced oral mucositis is still high. OM can decrease patients' oral intake and nutrition, leading to dehydration, weight loss, and declining performance status that may require intravenous fluid hydration, feeding tube placement, and hospitalization. OM also may increase opioid use. When severe, oral mucositis increases the risk of infection and may compromise clinical outcomes by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. Common clinical management strategies include bland rinses, topical anesthetics and analgesics, mucosal coating agents, and systemic analgesics. However, none of these interventions has been supported by conclusive evidence. 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.

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.

Eligibility 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, with intensity-modulated radiation therapy (IMRT).
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. 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.
2. Other conditions that the investigators consider as inappropriate for enrolling into this study.

Primary outcomes:
measure: Incidence of grade ≥ 3 mucositis
timeFrame: Day 56 after completion or termination of radiotherapy
measure: OMAS
timeFrame: Day 56 after completion or termination of radiotherapy
measure: OMDQ MTS question 2 (Q2) score
timeFrame: Day 56 after completion or termination of radiotherapy
measure: WHO score
timeFrame: Day 56 after completion or termination of radiotherapy
measure: EORTC QLQ-C30
timeFrame: Day 56 after completion or termination of radiotherapy
Secondary outcomes:
measure: Interruption time during the schedule of radiotherapy
timeFrame: Through radiotherapy completion or termination, an average of 7 weeks
measure: Time for healing of radiation-induced oral mucositis
timeFrame: Through study completion, an average of 15 weeks
measure: The cumulative dose of opioid used
timeFrame: Through study completion, an average of 15 weeks
measure: The cumulative time using opioid
timeFrame: Through study completion, an average of 15 weeks
measure: The change of body weight from baseline.
timeFrame: Baseline and 7 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
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