Study for the Prevention of Oral Mucositis (SPOM)

NCT05338398 | Unknown Phase 1 FDA Device

• 1 other identifier: BL002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• Prospective, Randomized, Questionnaire-Based Study
• Study Type: Phase 1/Phase 2 Interventional Clinical Trial
• Intervention Model: Parallel Assignment
• Masking: None (Open-label)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Primary Purpose: Supportive Care/Treatment
• Study groups
• Control Group (Group 1): Saline mouthwash (±Bocaliner™)
• Intervention Group (Group 2): Benzydamine mouthwash (±Bocaliner™)
• Settings
• Single-center (a specialized hematology center)
• Location: Hematology Center after Prof. R. Yeolyan, 7 Nersisyan St, Yerevan 0014, Armenia
• Subjects will initially be enrolled, consented, examined, and complete initial questionnaires in the healthcare provider's office Subjects will undergo initial evaluation and follow-up examinations to determine WHO Oral Mucositis Scores
• Subjects will complete questionnaires at the medical center with the Research Coordinator 7 and 14 days after study enrollment. Subjects using Bocaliner™ will additionally complete a follow-up questionnaire.
• Application of Bocaliner™ will be carried out first at the hospital followed by self-administration at home.

Conditions

Oral Mucositis

Keywords

Oral Mucositis; Chemotherapy; Inflammation; Benzydamine; Bocaliner; Medical Device; Prevention; Intervention; Pain; Oral Ulcerations

Outcome Measures

Primary Outcomes (1)

• Oral Mucositis Incidence (WHO Oral Toxicity Scale) during 2 weeks of follow-up

  A standard evaluation based on physical appearance of the oral mucosa and history

  Week 2

Secondary Outcomes (4)

• Change in Modified Patient-Reported Oral mucositis Symptom Score by 30 percent at 7 and 14 days. (Minimum Score 0, Maximum Score 1200). Higher Scores Mean Worse Outcome.

  Week 1 and 2

• Severity of oral mucositis (changes in World Health Organization's Oral Toxicity Scale). Minimum grade = 0, maximum grade= 4. Higher grade indicates worse outcome.

  Week 1 and 2

• Duration of oral mucositis (documented by the treating physician)

  Week 3

• Pain associated with oral mucositis (Modified Patient-Reported Oral mucositis Symptoms Score). Minimum score = 0, maximum score= 100. Higher score indicates worse outcome.

  Week 1 and 2

Other Outcomes (1)

• Safety and Tolerability of Bocaliner, an Orally Inserted Device in Patients Undergoing Chemotherapy (Phase 1 Trial)

  Baseline and week 2. (No score utilized. Descriptive analysis only.). Phase 1 data will be analyzed separately

Study Arms (2)

Control Group (Group 1): Standard Therapy

PLACEBO COMPARATOR

Group 1 will receive standard therapy with conventional oral care to prevent oral mucositis consisting of oral hygiene and rinses/mouthwashes with saline solutions 3-5 times daily. Half of the subjects in Group 1 will also receive Bocaliner™ devices

Device: Bocaliner

Intervention Group (Group 2): Benzydamine mouthwash

EXPERIMENTAL

Group 2 will receive benzydamine mouthwashes 3-5 times daily. Half of the subjects in Group 1 will also receive Bocaliner™ devices.

Drug: Benzydamine

Interventions

Bocaliner DEVICE

Bocaliner is a soft, orally inserted device that has been demonstrated to increase the oral retention of oral, topical therapies such as mouthwashes and gels.

Also known as: Oral topical medication retention device

Control Group (Group 1): Standard Therapy

Benzydamine DRUG

Benzydamine is an anti-inflammatory and antibiotic mouthwash that has shown promise for the treatment of radiation-induced oral mucositis.

Also known as: Anti-inflammatory and antibiotic mouthwash

Intervention Group (Group 2): Benzydamine mouthwash

Eligibility Criteria

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

You may qualify if:

• Diagnosed hematologic malignancy
• Ongoing chemotherapeutic treatment
• Properly obtained written informed consent
• Age of 18 years or older
• Willingness to use the study materials for at least 2 weeks, including
• Bocaliner™ device
• Benzydamine mouthwash
• Saline or baking soda mouthwash

You may not qualify if:

• No informed consent
• Systemic disease affecting oral mucosa
• Recurrent oral lesions other than oral mucositis
• Age of less than 18 years
• Recent invasive procedures of the mouth
• Use of medications affecting salivation (cholinergic, cholinomimetic, anti-cholinergic)
• Concurrent or previous radiotherapy
• Oral or maxillofacial disorders
• Inability/unwillingness to wear Bocaliner™ for the study period
• Unwillingness to use mouthwashes
• Known intolerance to silicone materials
• Known intolerance to benzydamine or any component of the formulation
• Individuals with significant 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

Yerevan, 0014, Armenia

Location

Related Publications (10)

• Daugelaite G, Uzkuraityte K, Jagelaviciene E, Filipauskas A. Prevention and Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis. Medicina (Kaunas). 2019 Jan 22;55(2):25. doi: 10.3390/medicina55020025.

  PMID: 30678228 BACKGROUND

• Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; 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. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.

  PMID: 32786044 BACKGROUND

• Elad S, Yarom N. The Search for an Effective Therapy and Pain Relief for Oral Mucositis. JAMA. 2019 Apr 16;321(15):1459-1461. doi: 10.1001/jama.2019.3269. No abstract available.

  PMID: 30990535 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Abstracts for MASCC/ISOO Annual Meeting 2019. Support Care Cancer. 2019 May 18:1-302. doi: 10.1007/s00520-019-04813-1. Online ahead of print. No abstract available.

  PMID: 31102057 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S. Oral mucositis and outcomes of allogeneic hematopoietic stem-cell transplantation in patients with hematologic malignancies. Support Care Cancer. 2007 May;15(5):491-6. doi: 10.1007/s00520-006-0176-9. Epub 2006 Dec 1.

  PMID: 17139495 BACKGROUND

• Oganesyan A, Harutyunyan L, Vanoyan A, Martirosyan N, Badikyan M, Gregory M, Oganesyan T, Ghahramanyan N, Ehrenpreis ED, Hakobyan Y. Tolerability and safety of a new oral device for prevention and treatment of oral mucositis in patients with hematologic malignancies undergoing chemotherapy. Support Care Cancer. 2025 Jul 31;33(8):733. doi: 10.1007/s00520-025-09722-0.

  PMID: 40742572 DERIVED

MeSH Terms

Conditions

Stomatitis; Inflammation; Pain; Oral Ulcer

Interventions

Benzydamine; Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yervand Hakobyan, MD

  Hematology Center after Prof. R. Yeolyan

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Control Group (Group 1): Standard Therapy Hematologic malignancy Saline mouthwash (±Bocaliner™) Intervention Group (Group 2): Benzydamine mouthwash Hematologic malignancy Benzydamine mouthwash (±Bocaliner™)

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 21, 2022
• Study Start: April 15, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

AR (1)