Evidence map›Paper›PMID 40742572›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

Tolerability and safety of a new oral device for prevention and treatment of oral mucositis in patients with hematologic malignancies undergoing chemotherapy.

Artem Oganesyan, Lusine Harutyunyan, Araksya Vanoyan, Nare Martirosyan, Maria Badikyan, Mark Gregory, Tigran Oganesyan, Nerses Ghahramanyan, Eli D Ehrenpreis, Yervand Hakobyan

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05338398 (A Phase 1/Phase 2 Study for the Prevention of Oral Mucositis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05338398 phase1 / phase2unknown statusnot on this map

A Phase 1/Phase 2 Study for the Prevention of Oral Mucositis (SPOM)

TypeinterventionalSponsorE2Bio Life Sciences, LLCRan2022 to 2023Enrolled100ConditionsOral MucositisArmsBocaliner, Benzydamine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Artem OganesyanDepartment of Hematology and Transfusion Medicine, National Institute of Health, 0051, Yerevan, Armenia.
Lusine HarutyunyanDepartment of Adult Hematology, Yeolyan Hematology and Oncology Center, 0014, Yerevan, Armenia.
Araksya VanoyanDepartment of Adult Hematology, Yeolyan Hematology and Oncology Center, 0014, Yerevan, Armenia.
Nare MartirosyanDepartment of Adult Hematology, Yeolyan Hematology and Oncology Center, 0014, Yerevan, Armenia.
Maria BadikyanDepartment of Adult Hematology, Yeolyan Hematology and Oncology Center, 0014, Yerevan, Armenia.
Mark GregoryWayne State University School of Medicine, Detroit, MI, 48201, USA.
Tigran OganesyanBIL Armenia, Healthcare Students' Association of Armenia, 0009, Yerevan, Armenia.
Nerses GhahramanyanDepartment of Adult Hematology, Yeolyan Hematology and Oncology Center, 0014, Yerevan, Armenia.
Eli D EhrenpreisDepartment of Medicine, Advocate Lutheran General Hospital, Park Ridge, IL, 60068, USA. Eli.Ehrenpreis@aah.org.
Yervand HakobyanDepartment of Hematology and Transfusion Medicine, National Institute of Health, 0051, Yerevan, Armenia.

Funding

E2Bio Life Sciences 2022002
6 · The paper itself

Abstract

purposeAround 40% of patients undergoing systemic chemotherapy develop oral mucositis (OM), a major cause of morbidity in cancer patients. There are only a few options for preventing and treating OM. This study examines the tolerability of a novel oral device (Bocaliner™), designed to enhance the effects of oral topical therapies, in patients with hematologic malignancies receiving chemotherapy.

methodsData from phase 1/phase 2 randomized controlled trial SPOM (Study for the Prevention of Oral Mucositis) was analyzed. Patients from the Yeolyan Hematology and Oncology Center (Yerevan, Armenia) were randomized into two groups: benzydamine or saline mouthwash. Half of the patients in each study group were randomly assigned to Bocaliner™. Tolerability and safety questionnaires on days 1 and 14 of chemotherapy were completed.

resultsTwenty-eight patients (mean age of 49 years; 50% female) received oral devices and completed the study. On the tryout of the device, 22 (78.6%) patients reported tolerating it well, and six (21.4%) reported some discomfort. After 14 days, 15 patients (35.7%) reported benefit from the use, with six (21.4%) of patients stating the device helped to reduce pain, four (14.3%) indicating that it helped them to eat, and five (17.8%) claiming both. Adverse events included discomfort (n = 2, 7.1%), pain around the cheekbone (n = 3, 10.7%), nausea (n = 2, 7.1%), and increased salivation (n = 1, 3.6%); none of these led to discontinuation of the use. Eighteen (64%) participants said they would use the device again. OM developed in five patients (17.8%).

conclusionsThe use of a new medical device designed to enhance oral topical medications in combination with oral topical therapy is well tolerated among patients with hematologic malignancies on chemotherapy.

trial registrationCLINICALTRIALS: gov registry ID: NCT05338398 (Date of registry: April 15, 2022).

Indexed as

Antineoplastic AgentsHematologic NeoplasmsMouthwashesStomatitisAdministration, OralAdultAgedFemaleHumansMaleMiddle AgedSurveys and QuestionnairesAntineoplastic AgentsMouthwashesChemotherapyOral mucositisPreventive medicineSupportive care

Identifiers

PMID40742572

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.