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

Launched by YUN-FEI XIA · Apr 6, 2016

Keywords

ClinConnect Summary

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 perfor...

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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.