A randomized, double-blind, placebo-controlled, parallel-group phase III clinical study to assess the efficacy and safety of soluble beta 1,3/1,6 glucan (SBG) on oral mucositis in head and neck cancer patients undergoing radiation therapy with or without chemotherapy

INTERVENTION: Product Name: Soluble Beta‐1,3/1,6‐glucan Pharmaceutical Form: Oral solution CAS Number: 53238‐80‐5 Current Sponsor code: SBG Other descriptive name: ß(1?3)/(1?6)‐D‐glucan Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use CONDITION: Oral mucositis ; MedDRA version: 9.1 Level: LLT Classification code 10028130 Term: Mucositis oral PRIMARY OUTCOME: Main Objective: To evaluate the efficacy and safety of SBG when administered from 1 day prior to 5 days after completion of radiotherapy. Primary end point(s): Incidence of oral mucositis CTC grade 3 or 4 at any time from commencement of radiotherapy up to 5 days after radiotherapy ceases Secondary Objective: • Compare the time from commencement of radiotherapy to onset of oral mucositis grade 3 or 4 in the SBG and placebo groups.; • Compare the duration of oral mucositis grade 3 or 4 in the SBG and placebo groups.; • Compare the overall incidence of oral mucositis grade 2, 3 and 4 in the SBG and placebo groups.; INCLUSION CRITERIA: 1. =18 years of age; 2. Patients with histologically confirmed carcinoma of the oral cavity, oropharynx, hypopharynx, supraglottic larynx, salivary glands or maxillary sinus; 3. Scheduled to receive an either conventional or altered fractionation external beam radiotherapy regimen for their head and neck cancer with or without concurrent chemotherapy; 4. At least two visible oral cavity anatomical sites must be included in the radiotherapy treatment volume and planned to receive a total radiation dose of 54 Gy or higher; 5. Normal oral mucosa at baseline (i.e. National Cancer Institute Common Toxicity Criteria [NCI‐CTC] oral mucositis grade 0); 6. Karnofsky score performance status =70% 7. Female patients must have a negative serum pregnancy test prior to receiving study medication, unless they have had a hysterectomy, or have been post‐menopausal for at least 1 year. Women with child bearing capacity must agree to use a medically accepted for