Oral MucositisEarly Phase 1MDOMNCT05104268
Study of a New Medical Device for Oral Mucositis
A Early Phase 1 study testing Bocaliner in people with Oral Mucositis and Stem Cell Transplant Complications, run by E2Bio Life Sciences, LLC at 1 site in Armenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Stem Cell Transplant Complications
- What is being tested?
- Bocaliner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteArmenia
- Study dates
- 30 Nov 2024to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of a New Medical Device for Oral Mucositis (MDOM Trial)
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.
Read the 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.
- Conditions
- Oral Mucositis, Stem Cell Transplant Complications
- Being tested
- Bocaliner
- Keywords
- Stem Cell Transplantation, Oral Mucositis, Cancer, Complications of chemotherapy, Oral Inflammation, Oral Pain, Pharmacokinetics, Oral Topical Therapy, Oral Inserted Device, Oral Resonance Time
- Medical subject headings
- Stomatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BocalinerDevice
Also called Standard Treatments for Oral Mucositis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bocaliner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 5, 10, and 14 days
Change of oral mucositis grade in the World Health Organization Grade,(WHO Mucositis Grade)
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.
Measured: 5, 10, and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start30 Nov 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Unable to recruit due to the relatively infrequent occurrence of oral mucositis. No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- E2Bio Life Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hematology Center after Prof. R. Yeolyan
- Responsible party
- Sponsor
- Investigators
- Yervand Hakoban, MD PhD, Principal investigator, Hematology Center after Prof. R. Yeolyan, MH RA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104268
- Sponsor's protocol ID
- BL001
- Acronym
- MDOM
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data will be available to other research scientists who meet screening criteria by principal investigator.
Publications
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.
PubMed 16601950Lalla 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.
PubMed 24615748Chaudhry 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.
PubMed 26409924Sio 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.
PubMed 30990550Kushner 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.
PubMed 18298885
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of a New Medical Device for Oral Mucositis (MDOM Trial)
- ClinicalTrials.gov ID
- NCT05104268
- Acronym / sponsor ID
- MDOM / BL001
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit due to the relatively infrequent occurrence of oral mucositis. No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- E2Bio Life Sciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Hematology Center after Prof. R. Yeolyan
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Device: BocalinerSubjects will then be randomized into two groups. The Standard Therapy Group will continue their usual therapy with oral topical agents for oral mucositis. |
| Bocaliner | Experimental | Device: BocalinerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BocalinerAlso: Standard Treatments for Oral MucositisBocaliner 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. | Device | Bocaliner, Standard Therapy |
Primary outcome
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.
2 secondary outcomes
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
Change of oral mucositis grade in the World Health Organization Grade,(WHO Mucositis Grade)
Time frame: 5, 10, and 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publication: PubMed 16601950Jones 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.
- Results publication: PubMed 24615748Lalla 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.
- Results publication: PubMed 26409924Chaudhry 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.
- Results publication: PubMed 30990550Sio 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.
- Results publication: PubMed 18298885Kushner 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.
- Individual participant dataSharing planned: Yes. Deidentified data will be available to other research scientists who meet screening criteria by principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yervand Hakoban, MD PhD principal investigator
Hematology Center after Prof. R. Yeolyan, MH RA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bocaliner in people with Oral Mucositis and Stem Cell Transplant Complications, run by E2Bio Life Sciences, LLC at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire) Pain Score (time frame: 5, 10, and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104268, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.