Study for the Prevention of Oral Mucositis (SPOM) (SPOM)
Oral Mucositis
About this trial
This is an interventional prevention trial for Oral Mucositis focused on measuring Oral Mucositis, Chemotherapy, Inflammation, Benzydamine, Bocaliner, Medical Device, Prevention, Intervention, Pain, Oral Ulcerations
Eligibility Criteria
Inclusion Criteria
- Diagnosed hematologic malignancy
- Ongoing chemotherapeutic treatment
- Properly obtained written informed consent
- Age of 18 years or older
Willingness to use the study materials for at least 3 weeks, including
- Bocaliner™ device
- Benzydamine mouthwash
- Saline or baking soda mouthwash
Exclusion Criteria:
- No informed consent
- Systemic disease affecting oral mucosa
- Recurrent oral lesions other than oral mucositis
- Age of less than 18 years
- Recent invasive procedures of the mouth
- Use of medications affecting salivation (cholinergic, cholinomimetic, anti-cholinergic)
- Concurrent or previous radiotherapy
- Oral or maxillofacial disorders
- Inability/unwillingness to wear Bocaliner™ for the study period
- Unwillingness to use mouthwashes
- Known intolerance to silicone materials
- Known intolerance to benzydamine or any component of the formulation
- Individuals with significant difficulties to communicate and understand
Sites / Locations
- Hematology Center after Prof. R. Yeolyan
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Control Group (Group 1): Standard Therapy
Intervention Group (Group 2): Benzydamine mouthwash
Group 1 will receive standard therapy with conventional oral care to prevent oral mucositis consisting of oral hygiene and rinses/mouthwashes with saline solutions 3-5 times daily. Half of the subjects in Group 1 will also receive Bocaliner™ devices
Group 2 will receive benzydamine mouthwashes 3-5 times daily. Half of the subjects in Group 1 will also receive Bocaliner™ devices.