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

Yun-fei Xia

Status and phase: Unknown; Phase 2

Conditions: Stomatitis; Nasopharyngeal Neoplasms

Treatments: Drug: Oral Ulcer Gargle (FORRAD®); Drug: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02735317

B2015-074-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

FORRAD group

Experimental group

Description:

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.

Treatment:

Drug: Oral Ulcer Gargle (FORRAD®)

Quadruple mixture group

Active Comparator group

Description:

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.

Treatment:

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