Study of a New Medical Device for Oral Mucositis (MDOM)

• ClinicalTrials.gov Identifier: NCT05104268
• Recruitment Status: Not yet recruiting
• First Posted: November 2, 2021
• Last Update Posted: November 23, 2021
• Sponsor: E2Bio Life Sciences, LLC
• Collaborator: Hematology Center after Prof. R. Yeolyan
• Information provided by (Responsible Party): E2Bio Life Sciences, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Oral Mucositis; Stem Cell Transplant Complications	Device: Bocaliner	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Study of a New Medical Device for Oral Mucositis (MDOM Trial)
• Estimated Study Start Date: November 30, 2021
• Estimated Primary Completion Date: May 15, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard Therapy; 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; 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.; Other Name: Standard Treatments for Oral Mucositis
Experimental: 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.	Device: Bocaliner; 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.; Other Name: Standard Treatments for Oral Mucositis

Outcome Measures

Primary Outcome Measures :

1. Change in Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire) Pain Score [ Time Frame: 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 :

1. Change in other symptoms of oral mucositis on the Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire. [ Time Frame: 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.
2. Change of oral mucositis grade in the World Health Organization Grade,(WHO Mucositis Grade) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Eli D Ehrenpreis, MD; 8479771318; e2bioconsults@gmail.com

Contact: Artem T Oganesyan, MD; +374 10 283800; a.t.oganesyan@gmail.com

Locations

Armenia

Hematology Center after Prof. R. Yeolyan MH RA

Yerevan, Armenia, 0014

Contact: Yervand Hakobyan, MD TBA armhema@gmail.com

Contact: Artem Oganesyan, MD TBA A.T.oganseyan@gmail.com

Sponsors and Collaborators

E2Bio Life Sciences, LLC

Hematology Center after Prof. R. Yeolyan

Investigators

• Principal Investigator: Yervand Hakoban, MD PhD; Hematology Center after Prof. R. Yeolyan, MH RA

More Information

Publications of Results:

Jones JA, Avritscher EB, Cooksley CD, Michelet M, Bekele BN, Elting LS. Epidemiology of treatment-associated mucosal injury after treatment with newer regimens for lymphoma, breast, lung, or colorectal cancer. Support Care Cancer. 2006 Jun;14(6):505-15. Epub 2006 Apr 7. Review.

Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, McGuire DB, Migliorati C, Nicolatou-Galitis O, Peterson DE, Raber-Durlacher JE, Sonis ST, Elad S; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014 May 15;120(10):1453-61. doi: 10.1002/cncr.28592. Epub 2014 Feb 25. Review. Erratum in: Cancer. 2015 Apr 15;121(8):1339.

Chaudhry HM, Bruce AJ, Wolf RC, Litzow MR, Hogan WJ, Patnaik MS, Kremers WK, Phillips GL, Hashmi SK. The Incidence and Severity of Oral Mucositis among Allogeneic Hematopoietic Stem Cell Transplantation Patients: A Systematic Review. Biol Blood Marrow Transplant. 2016 Apr;22(4):605-616. doi: 10.1016/j.bbmt.2015.09.014. Epub 2015 Sep 26. Review.

Sio TT, Le-Rademacher JG, Leenstra JL, Loprinzi CL, Rine G, Curtis A, Singh AK, Martenson JA Jr, Novotny PJ, Tan AD, Qin R, Ko SJ, Reiter PL, Miller RC. Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1481-1490. doi: 10.1001/jama.2019.3504.

Kushner JA, Lawrence HP, Shoval I, Kiss TL, Devins GM, Lee L, Tenenbaum HC. Development and validation of a Patient-Reported Oral Mucositis Symptom (PROMS) scale. J Can Dent Assoc. 2008 Feb;74(1):59.

• Responsible Party: E2Bio Life Sciences, LLC
• ClinicalTrials.gov Identifier: NCT05104268
• Other Study ID Numbers: BL001
• First Posted: November 2, 2021
• Last Update Posted: November 23, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Deidentified data will be available to other research scientists who meet screening criteria by principal investigator.
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: January 2023 through January 2024

Access Criteria

1. Data scientists from accredited clinical organizations
2. Accepted review by principal investigator for the planned purpose for data use

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by E2Bio Life Sciences, LLC:

Stem Cell Transplantation; Oral Mucositis; Cancer; Complications of chemotherapy; Oral Inflammation; Oral Pain; Pharmacokinetics; Oral Topical Therapy; Oral Inserted Device; Oral Resonance Time

Additional relevant MeSH terms:

Mucositis; Stomatitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases