Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)

Inclusion Criteria:

• Male and female patients of any ethnic origin ≥18 years of age.
• Patients diagnosed with stage III or IV Head and Neck cancer (histologic or cytologicdiagnosis), according to VIII AJCC staging system, who are candidate and are about tostart RT, with or without concomitant CT, with curative intent, either with exclusiveor postoperative intent.
• Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1,or 2.
• Patients legally capable of giving their consent to participate in the study andavailable to sign and date the written informed consent and the Declaration of consentfor the processing of personal data.
• Women of childbearing potential or with no menses for a period < 12 months must have anegative pregnancy test at Visit 0 and have to agree not to start a pregnancy from thesignature of the informed consent up to the end of the study, using an appropriatebirth control method, such as combined oestrogen-progestin containing hormonalcontraceptives (e.g., oral, injectable, transdermal), progestin-only hormonalcontraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) orIntrauterine hormone-releasing System (IUS) in combination with male condom, bilateraltubal occlusion, vasectomised partner, sexual abstinence. The following definitionswill be considered:
• Woman of childbearing potential (WOCBP): i.e., fertile, following menarche anduntil becoming post-menopausal, unless permanently sterile. Permanentsterilization methods include hysterectomy, bilateral salpingectomy and bilateraloophorectomy.

Exclusion Criteria:

• Patients with reported allergy to benzydamine or another component of the formulationused.
• Any contraindications listed in the local product's Summary of Product Characteristics (SmPCs).
• Patients with prior head and neck RT (in the previous 6 months), or patient whoreceived a palliative treatment.
• Patients with distant metastatic disease and/or severe cognitive impairment and/orclinically symptomatic brain metastases and/or patients with significant comorbidconditions.
• Patients with mucositis due to other medical conditions (e.g., gastro-oesophagealreflux, autoimmune disease, etc.).
• Patients who use other oromucosal products (over the counter or prescription) for thesame disease.
• Prescription of other rinses (anaesthetics like "magic mouthwashes" or others), exceptfrom sodium bicarbonate rinses.
• Use of chlorhexidine, other anti-inflammatory mouthwashes solutions, misoprostol,granulocyte macrophage colony-stimulating factor (GM-CSF) and sucralfate gel.
• Employment of antifungal or antibiotic drugs as prophylaxis for mucositis; anytherapeutic use in case of overt clinical infections is allowed.
• Patients treated with other therapies that can cause mucositis, except for thetherapies for their primary condition.
• Patients treated with any topical anti-inflammatory/analgesic products for themucositis.
• Any other product that can interfere with the evaluation of pain or inflammatorystate, according to the Investigator's assessment.