Prevention of Oral Mucositis (SPOM)

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: E2Bio Life Sciences, LLC
• Collaborator: Hematology Center after Prof. R. Yeolyan
• Treatments: Anti-Bacterial Agents; Anti-Inflammatory Agents; Benzydamine

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)

• Chronic use of anti-inflammatory, analgesic, antibiotic medications

• 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