Study of a New Medical Device for Oral Mucositis (MDOM)
Oral Mucositis, Stem Cell Transplant Complications
About this trial
This is an interventional supportive care trial for Oral Mucositis focused on measuring Stem Cell Transplantation, Oral Mucositis, Cancer, Complications of chemotherapy, Oral Inflammation, Oral Pain, Pharmacokinetics, Oral Topical Therapy, Oral Inserted Device, Oral Resonance Time
Eligibility Criteria
Inclusion Criteria:
- Symptomatic chemotherapy-induced oral mucositis
- Need for oral topical therapy for symptomatic treatment
- Absence of other chronic oral disorders
- Properly obtained written informed consent
- Age of 18 years or older
- Patient is willing to use the Bocaliner™ device for 2 weeks
- No concurrent use of medications modulating pain
Exclusion Criteria:
- Chronic oral conditions other than chemotherapy-induced oral mucositis
- No informed consent
- Age of <18
- Inability to place the device in his/her mouth and keep it in place for at least 10 minutes due to severe oral pain, large lesions, or any other reason
- Inability/unwillingness to wear Bocaliner™ for the study period
- Concurrent use of pain-modulating agents
- Individuals with known allergies to silicone materials
- Individuals with severe difficulties to communicate and understand
Sites / Locations
- Hematology Center after Prof. R. Yeolyan MH RA
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Therapy
Bocaliner
Subjects will then be randomized into two groups. The Standard Therapy Group will continue their usual therapy with oral topical agents for oral mucositis.
Participants that are randomized to the Bocaliner Group will place Bocaliner™ inside of their mouth for 5 minutes and fill out the Initial Bocaliner™ Questionnaire. They will then continue all original therapy for oral mucositis, including oral topical treatments and general hygiene, 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.