Oral mucositis MedDRA version: 9.1 Level: LLT Classification code 10028130 Term: Mucositis oral
Conditions
Sponsors
Biotec Pharmacon ASA
Eligibility
Sex/Gender
All
Inclusion criteria
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 form of contraception throughout the study period; 8. Willing and able to provide written informed consent for study participation; 9. Willing and able to complete other protocol-specified evaluations according to the study schedule. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous head and neck cancer; 2. History of, or clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis: i. Symptomatic and/or uncontrolled cardiac disease, New York Heart Association (NYHA) grade III/IV, transmural myocardial infarction or stroke within the last 6 months; ii. Known sero-positivity for hepatitis B or hepatitis C virus (testing not required for study entry); iii. Known sero-positivity for human immunodeficiency virus (HIV) or patients with acquired immune deficiency syndrome (AIDS) (testing not required for study entry); iv. Acute bacterial or fungal infection requiring intravenous antibiotics at study entry; v. Immunology disorders such as scleroderma or any other medical condition requiring chronic use of systemic corticosteroids. 3. Patients expected to receive other oral mucositis treatment or preventative agents during the study as described in Section ?7.3 Prohibited Medication; 4. Patients who received previous radiotherapy in the head and neck area; 5. Patients who received chemotherapy within the past 6 months before screening; 6. Receipt of any investigational product within 30 days prior to this study; 7. Any patient who, in the opinion of the Investigator, is unlikely to comply with the study procedures, or is unlikely to complete the study due to different reasons e.g. language barriers or mental incapacity; 8. Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France, Germany
Outcome results
None listed