Study of a New Medical Device for Oral Mucositis

Early Phase 1

Withdrawn

• Conditions: Oral Mucositis; Stem Cell Transplant Complications
• Interventions: Device: Bocaliner

• Registration Number: NCT05104268
• Lead Sponsor: E2Bio Life Sciences, LLC

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Study Start: 2024-11-30
• Primary Completion: 2025-05-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
Bocaliner	Bocaliner	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.

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire) Pain Score	5, 10, and 14 days	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.

Secondary Outcome Measures

Name	Time	Method
Change of oral mucositis grade in the World Health Organization Grade,(WHO Mucositis Grade)	5, 10, and 14 days	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.
Change in other symptoms of oral mucositis on the Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire.	5, 10, and 14 days	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.

Trial Locations

Locations (1)

Hematology Center after Prof. R. Yeolyan MH RA; 🇦🇲 Yerevan, Armenia