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Study for the Prevention of Oral Mucositis (SPOM)

NCT05338398 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-08

No results posted yet for this study

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.

Conditions

  • Oral Mucositis

Interventions

DEVICE

Bocaliner

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.

DRUG

Benzydamine

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

Sponsors & Collaborators

  • Hematology Center after Prof. R. Yeolyan

    collaborator UNKNOWN

  • E2Bio Life Sciences, LLC

    lead INDUSTRY

Principal Investigators

  • Yervand Hakobyan, MD · Hematology Center after Prof. R. Yeolyan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2023-10-30
Completion
2023-12-31
FDA Device
Yes

Countries

  • Armenia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338398 on ClinicalTrials.gov