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NCT ID: NCT05338398 Enrolling by invitation - Oral Mucositis Clinical Trials

Study for the Prevention of Oral Mucositis (SPOM)

SPOM
Start date: April 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

1. Study Design - Prospective, Randomized, Questionnaire-Based Study - Study Type: Phase 1/Phase 2 Interventional Clinical Trial - Intervention Model: Parallel Assignment - Masking: None (Open-label) - Actual Enrollment: 100 participants - Allocation: Randomized - Primary Purpose: Supportive Care/Treatment - Study groups - Control Group (Group 1): Saline mouthwash (±Bocaliner™) - Intervention Group (Group 2): Benzydamine mouthwash (±Bocaliner™) 2. Settings - Single-center (a specialized hematology center) - Location: Hematology Center after Prof. R. Yeolyan, 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 and 14 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.