Study for the Prevention of Oral Mucositis (SPOM)

Summary

1. Study Design * 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™) 2. 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.

Timeline

Start

2022-04-15

Primary completion

2023-10-30

Completion

2023-12-31

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications