A Phase 1/Phase 2 Study for the Prevention of Oral Mucositis (SPOM)

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 chemotherapeutic treatment for a diagnosed hematologic malignancy and at risk for oral mucositis will be enrolled. All subjects will sign an informed consent form prior to enrollment.

Initially, subjects will undergo a general oral examination to determine any significant dental or oral problems. Patients will be examined by study team members for potential eligibility. Subjects will then be randomized into two groups. Group 1 will receive standard therapy with conventional oral care to prevent oral mucositis consisting of oral hygiene and rinses/mouthwashes with saline solutions 3-5 times daily for at least 2 consecutive weeks. Group 2 will receive benzydamine mouthwashes 3-5 times daily for at least 2 consecutive weeks. Half of the subjects in each group will also receive Bocaliner™ devices along with cleaning materials with instructions about device use and cleaning based on another randomization. Bocaliner™ will be used with each topical treatment (either standard treatment or benzydamine mouthwash) for oral mucositis 3-5 times per day for 2 weeks. Allocation to each study group as well as the receipt of Bocaliner™ as an adjunct to the prevention strategy will be determined by randomization.

Subjects assigned to receive Bocaliner™ will initially place the device inside of their mouth for 5 minutes and fill out the Initial Bocaliner™ Questionnaire. The subjects will then continue all original therapy for oral mucositis including oral topical treatments and will place the Bocaliner™ device inside of their mouth and hold it in place up to 40 minutes as instructed after each topical treatment. The device is hypothesized to improve the effects of treatments.

All subjects will be contacted by the Research Coordinator at 7 and 14 days after enrollment and undergo an oral examination using the WHO Oral Toxicity Scale (Days 7 and 14). Subjects receiving Bocaliner™ will describe their use of the device on the Bocaliner™ Follow up Questionnaire (Day 14). Subjects are instructed to contact their physicians whenever oral mucositis develops. Following detailed examination, the subjects will be asked to answer the questions from the Modified PROMS Questionnaire.