Study of a New Medical Device for Oral Mucositis

Study Overview
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Brief Summary
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This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment. The goal of this study is to determine tolerance and response to the use of Bocaliner™ as reported by patients with chemotherapy and/or radiation therapy-induced oral mucositis.

Detailed Description
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All patients will be referred by their treating physicians to the designated study healthcare providers. Patients will have been diagnosed with oral mucositis and will be receiving oral topical medication for oral pain as well as other problems related to oral mucositis. All subjects will sign an informed consent form. Initially, subjects will undergo an oral examination and for determination of the World Health Organization (WHO) Oral Toxicity Scale and will then complete a General Oral Mucositis Assessment Scale. Subjects will then be randomized into two groups. Group 1 will continue standard therapy with oral topical agents for oral mucositis. Group 2 will additionally receive Bocaliner™ devices along with cleaning materials with instructions about device use and cleaning. Subjects in the Group 2 will use Bocaliner™ with each topical treatment for oral mucositis up to 5 times per day for 2 weeks or shorter if not tolerated. Subjects assigned to the Group 1 will continue the original therapy for oral mucositis, including oral topical treatments and general hygiene measures. Participants that are randomized to the Group 2 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. All subjects will be contacted by the Research Coordinator via phone call at 5 and 10 days after the initial enrollment and invited to answer the questions from the Modified PROMS Questionnaire at the hospital. Alternatively, the questionnaire can be provided via email, or the questions can be answered via phone call, if preferred by a patient. Subjects in Group 2 will describe their experience of using Bocaliner™ through the Bocaliner™ Follow-up Questionnaire. All subjects will give a detailed description of their current medication usage for oral mucositis. Participants from both groups will return to their practitioners after 14 days and undergo a general oral examination. The WHO Oral Toxicity Scale will be used to assess the grade of oral mucositis. Subjects will also complete the Modified PROMS Questionnaire at days 5, 10, and 14 to understand the impact of standard treatment vs Bocaliner™ on symptoms related to oral mucositis.

Official Title
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A Randomized Study of a New Medical Device for Oral Mucositis (MDOM Trial)

Conditions
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Oral Mucositis, Stem Cell Transplant Complications

Intervention / Treatment
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* Device: Bocaliner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will then be randomized into two groups. Group 1 will continue standard therapy with oral topical agents for oral mucositis. Group 2 will additionally receive Bocaliner™ devices along with cleaning materials with instructions about device use and cleaning. Subjects in the Group 2 will use Bocaliner™ with each topical treatment for oral mucositis up to 5 times per day for 2 weeks or shorter if not tolerated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy<br>Subjects will then be randomized into two groups. The Standard Therapy Group will continue their usual therapy with oral topical agents for oral mucositis. | Device: Bocaliner<br>* Bocaliner is an orally inserted device that is held within the mouth following the administration of mouthwashes, gels, and rinses that are used to treat pain associated with oral mucositis, and to reduce inflammation and to accelerate healing of oral mucositis.<br>* Other names: Standard Treatments for Oral Mucositis;|
| Experimental: Bocaliner<br>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. | Device: Bocaliner<br>* Bocaliner is an orally inserted device that is held within the mouth following the administration of mouthwashes, gels, and rinses that are used to treat pain associated with oral mucositis, and to reduce inflammation and to accelerate healing of oral mucositis.<br>* Other names: Standard Treatments for Oral Mucositis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire) Pain Score | The modified PROMS score is designed to measure symptoms and quality of life in patients with oral mucositis. It consists of twelve questions. The range in scores for each section is 0 to 100. Higher scores on the Modified PROMS indicate worse outcomes. The range in the Pain Score of the Modified PROMS Questionnaire is from 0 to 100. | 5, 10, and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other symptoms of oral mucositis on the Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire. | The modified PROMS score is designed to measure symptoms and quality of life in patients with oral mucositis. It consists of twelve questions. The range in scores for each question is 0 to 100. Higher scores on the PROMS Questionnaire indicate worse outcomes. | 5, 10, and 14 days | 
| Change of oral mucositis grade in the World Health Organization Grade,(WHO Mucositis Grade) | The WHO Mucositis grade is based on the appearance of the oral mucosa and the effect of oral mucositis on nutritional intake. The range of grades is from 1 to 4. Higher WHO Mucositis grades indicate worse outcomes. | 5, 10, and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Pain, Stem Cell Transplantation, Oral Mucositis, Cancer, Complications of chemotherapy, Oral Inflammation, Pharmacokinetics, Oral Topical Therapy, Oral Inserted Device, Oral Resonance Time