1. Study Design
- Prospective, Randomized, Questionnaire-Based Study
- Study Type: Interventional Clinical Trial
- Intervention Model: Parallel Assignment
- Masking: None (Open label)
- Actual Enrollment: 88 participants
- Allocation: Randomized
- Primary Purpose: Supportive Care/Treatment Study groups Group 1-Standard oral care
+/- Bocaliner Group 2 Benzydamine mouthwash +/- Bocaliner
2. Settings
- Single center (a specialized hematology center)
- Location: Yeolyan Hematology Center, 7 Nersisyan St, Yerevan 0014, Armenia
- Subjects will initially be enrolled, consented, examined and complete initial
questionnaires in the healthcare provider's office Subjects will undergo initial
evaluation and follow up examinations to determine WHO Oral Mucositis Scores
- Subjects will complete questionnaires at the medical center with the Research
Coordinator 7, 14, and 21 days after study enrollment. Subjects using Bocaliner™
will additionally complete a follow-up questionnaire.
- Application of Bocaliner™ will be carried out first at the hospital followed by
self-administration at home.