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A multicenter randomized controlled trial of betamethasone-based mouthwash for the prevention of oral mucositis

A multicenter randomized controlled trial of betamethasone-based mouthwash for the prevention of oral mucositis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071240060
Enrollment
312
Registered
2024-09-20
Start date
2024-12-10
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumors except for head and neck and hematologic cancers solid tumour, oralmucositis

Interventions

Study arm: mouthwash with betamethasone Control arm: mouthwash with azunol

Sponsors

Soutome Sakiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing chemotherapy for solid tumors except head and neck and hematologic cancers at participating centers. Any type or combination of anticancer drugs, molecular targeted drugs, and immune checkpoint inhibitors. (2) Patients who are 18 years or older at the time of consent are obtained. (3) Patients who can personally provide written consent of their own free will after receiving a thorough explanation of the study and fully understanding their participation in the study

Exclusion criteria

Exclusion criteria: 1) Patients with a history of hypersensitivity to betamethasone sodium phosphate 2) Patients who cannot be gargle 3) Patients who have already developed oral mucositis 4) Patients with oral candidiasis 5) Patients deemed inappropriate for inclusion in the study by the principal investigator or sub investigators

Design outcomes

Primary

MeasureTime frame
Presence and timing of onset of Grade 1 oral mucositis

Secondary

MeasureTime frame
Presence and timing of onset of Grade 2 and 3 oral mucositis Onset and timing of oral candidiasis Completion of chemotherapy or not

Contacts

Public ContactSakiko Soutome

Nagasaki University Hospital

sakiko@nagasaki-u.ac.jp+81-95-819-7663

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026