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Study of a New Medical Device for Oral Mucositis (MDOM)

Primary Purpose

Oral Mucositis, Stem Cell Transplant Complications

Status
Not yet recruiting
Phase
Phase 1
Locations
Armenia
Study Type
Interventional
Intervention
Bocaliner
Sponsored by
E2Bio Life Sciences, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring Stem Cell Transplantation, Oral Mucositis, Cancer, Complications of chemotherapy, Oral Inflammation, Oral Pain, Pharmacokinetics, Oral Topical Therapy, Oral Inserted Device, Oral Resonance Time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hematology Center after Prof. R. Yeolyan MH RA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Therapy

Bocaliner

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 21, 2021
Last Updated
November 21, 2021
Sponsor
E2Bio Life Sciences, LLC
Collaborators
Hematology Center after Prof. R. Yeolyan
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1. Study Identification

Unique Protocol Identification Number
NCT05104268
Brief Title
Study of a New Medical Device for Oral Mucositis
Acronym
MDOM
Official Title
A Randomized Study of a New Medical Device for Oral Mucositis (MDOM Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2021 (Anticipated)
Primary Completion Date
May 15, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
E2Bio Life Sciences, LLC
Collaborators
Hematology Center after Prof. R. Yeolyan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Bocaliner
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Bocaliner
Other Intervention Name(s)
Standard Treatments for Oral Mucositis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire) Pain Score
Description
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.
Time Frame
5, 10, and 14 days
Secondary Outcome Measure Information:
Title
Change in other symptoms of oral mucositis on the Patient-Reported Oral Mucositis Symptom (The Modified PROMS Questionnaire.
Description
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.
Time Frame
5, 10, and 14 days
Title
Change of oral mucositis grade in the World Health Organization Grade,(WHO Mucositis Grade)
Description
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.
Time Frame
5, 10, and 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli D Ehrenpreis, MD
Phone
8479771318
Email
e2bioconsults@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Artem T Oganesyan, MD
Phone
+374 10 283800
Email
a.t.oganesyan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yervand Hakoban, MD PhD
Organizational Affiliation
Hematology Center after Prof. R. Yeolyan, MH RA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology Center after Prof. R. Yeolyan MH RA
City
Yerevan
ZIP/Postal Code
0014
Country
Armenia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yervand Hakobyan, MD
Phone
TBA
Email
armhema@gmail.com
First Name & Middle Initial & Last Name & Degree
Artem Oganesyan, MD
Phone
TBA
Email
A.T.oganseyan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be available to other research scientists who meet screening criteria by principal investigator.
IPD Sharing Time Frame
January 2023 through January 2024
IPD Sharing Access Criteria
Data scientists from accredited clinical organizations Accepted review by principal investigator for the planned purpose for data use
Citations:
PubMed Identifier
16601950
Citation
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.
Results Reference
result
PubMed Identifier
24615748
Citation
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. Erratum In: Cancer. 2015 Apr 15;121(8):1339.
Results Reference
result
PubMed Identifier
26409924
Citation
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.
Results Reference
result
PubMed Identifier
30990550
Citation
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.
Results Reference
result
PubMed Identifier
18298885
Citation
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.
Results Reference
result

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Study of a New Medical Device for Oral Mucositis

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