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

JRCT ID: jRCTs071240060

Registered date:20/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid tumors except for head and neck and hematologic cancers
• Date of first enrollment: 20/09/2024
• Target sample size: 312
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Presence and timing of onset of Grade 1 oral mucositis

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Soutome Sakiko
• Source(s) of Monetary Support: Kakenhi (Grants-in-Aid for Scientific Research)