Study of a New Medical Device for Oral Mucositis

NCT05104268 | Withdrawn Early Phase 1 DMC FDA Device

• 1 other identifier: BL001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis; Stem Cell Transplant Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in other symptoms of oral mucositis on the Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire.

  5, 10, and 14 days

• Change of oral mucositis grade in the World Health Organization Grade,(WHO Mucositis Grade)

  5, 10, and 14 days

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

Bocaliner DEVICE

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.

Also known as: Standard Treatments for Oral Mucositis

Bocaliner; Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• E2Bio Life Sciences, LLC: lead
• Hematology Center after Prof. R. Yeolyan: collaborator

Study Sites (1)

Hematology Center after Prof. R. Yeolyan MH RA

Yerevan, 0014, Armenia

Location

Related Publications (5)

• 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. doi: 10.1007/s00520-006-0055-4. Epub 2006 Apr 7.

  PMID: 16601950 RESULT

• 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.

  PMID: 24615748 RESULT

• 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.

  PMID: 26409924 RESULT

• 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.

  PMID: 30990550 RESULT

• 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.

  PMID: 18298885 RESULT

MeSH Terms

Conditions

Stomatitis; Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yervand Hakoban, MD PhD

  Hematology Center after Prof. R. Yeolyan, MH RA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: November 30, 2024
• Primary Completion: May 15, 2025
• Study Completion: December 31, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

AR (1)