Status:
UNKNOWN
Study for the Prevention of Oral Mucositis (SPOM)
Lead Sponsor:
E2Bio Life Sciences, LLC
Collaborating Sponsors:
Hematology Center after Prof. R. Yeolyan
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
1. Study Design * Prospective, Randomized, Questionnaire-Based Study * Study Type: Phase 1/Phase 2 Interventional Clinical Trial * Intervention Model: Parallel Assignment * Masking: None ...
Detailed Description
This is a single-center randomized controlled trial . The goal of this study is to find whether topical benzydamine is superior in preventing chemotherapy-induced oral mucositis compared to standard m...
Eligibility Criteria
Inclusion
- 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 2 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
Exclusion
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05338398
Start Date
April 15 2022
End Date
December 31 2023
Last Update
September 8 2023
Active Locations (1)
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1
Hematology Center after Prof. R. Yeolyan
Yerevan, Armenia, 0014