Clinical trial · Interventional
Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)
Phase IV Study on the Feasibility of a Preventative/Therapeutic Approach With Benzydamine Oromucosal Solution in Radiation-induced Oral Mucositis (OM) in Patients With Head and Neck Cancer (HNC)
NCT05055726CI-TRIAL-00062218BOOMcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present study is to collect data on the feasibility of a preventative/therapeutic approach of radiation-induced oral mucositis with benzydamine oromucosal solution (mouthwash) in patients with head and neck cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation-Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Benzydamine Hydrochloride 0.15% w/v oromucosal solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Benzydamine Hydrochloride 0.15% w/v oromucosal solution
- description
- Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A., is assigned to the patients for radiation-induced oromucositis. The patients take at home 15 ml (1 tablespoon) of concentrated or diluted (with water) mouthwash 2-3 times a day, but not more than 5 times a day, washing the mouth and throat for 20-30 seconds, according to the Investigator's indications and the local product's SmPC. In Hungary, the therapy should started with diluted product (15 ml of water + 15 ml of concentrated solution). After that, gargling can be continued with 15 ml (1 tablespoon) of concentrated mouthwash, generally 2-3 times a day, but not more than 5 times a day. In Poland, the solution is used 2 to 3 times daily; at a single time, it should be used approximately 15 ml of concentrated or diluted mouthwash with a small amount of water and wash the mouth and throat for 20 to 30 seconds.
- interventionNames
- Drug: Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Primary outcomes (1)
- measure
- Number of responders
- timeFrame
- Up to 7 weeks
- description
- The effectiveness of benzydamine oromucosal solution (mouthwash) in the prevention/tratment of radiation-induced oral mucositis in Head and Neck cancer patients is evaluated as the number of responders, expressed in percentage, defined as the number of head and neck cancer patients with oral mucositis pain intensity \<5 in the Numeric Rating Scale.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 cytologic diagnosis), according to VIII AJCC staging system, who are candidate and are about to start RT, with or without concomitant CT, with curative intent, either with exclusive or 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 and available to sign and date the written informed consent and the Declaration of consent for the processing of personal data. * Women of childbearing potential or with no menses for a period \< 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the end of the study, using an appropriate birth control method, such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered: * Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Exclusion Criteria: * Patients with reported allergy to benzydamine or another component of the formulation used. * 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 who received a palliative treatment. * Patients with distant metastatic disease and/or severe cognitive impairment and/or clinically symptomatic brain metastases and/or patients with significant comorbid conditions. * Patients with mucositis due to other medical conditions (e.g., gastro-oesophageal reflux, autoimmune disease, etc.). * Patients who use other oromucosal products (over the counter or prescription) for the same disease. * Prescription of other rinses (anaesthetics like "magic mouthwashes" or others), except from 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; any therapeutic use in case of overt clinical infections is allowed. * Patients treated with other therapies that can cause mucositis, except for the therapies for their primary condition. * Patients treated with any topical anti-inflammatory/analgesic products for the mucositis. * Any other product that can interfere with the evaluation of pain or inflammatory state, according to the Investigator's assessment.
References
Publications (0)
Data not yet available
No reference posted for this study.