Clinical trial · Interventional
Study of a New Medical Device for Oral Mucositis
A Randomized Study of a New Medical Device for Oral Mucositis (MDOM Trial)
NCT05104268CI-TRIAL-00074107MDOMwithdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Why stopped (as posted): Unable to recruit due to the relatively infrequent occurrence of oral mucositis. No participants enrolled
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
| Stem Cell Transplant Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bocaliner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Therapy
- description
- Subjects will then be randomized into two groups. The Standard Therapy Group will continue their usual therapy with oral topical agents for oral mucositis.
- interventionNames
- Device: Bocaliner
- type
- EXPERIMENTAL
- label
- Bocaliner
- description
- 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.
- interventionNames
- Device: Bocaliner
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTJones 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
- RESULTLalla 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
- RESULTChaudhry 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
- RESULTSio 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
- RESULTKushner 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