Study for the Prevention of Oral Mucositis (SPOM)

Launched by E2BIO LIFE SCIENCES, LLC · Apr 15, 2022

Keywords

ClinConnect Summary

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 methods, which include oral rinses with saline. This study also aims to determine the tolerance and response to the use of Bocaliner™ (a new medical device designed to improve treatment and prevention of oral mucositis) in the prevention of oral mucositis.

All patients will be referred by their treating physicians to the designated study healthcare providers. Patients undergoing chemotherapeuti...

Gender

ALL

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 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