SMASH (Steroid Mouthwash for the Prevention of Oral Mucositis in Breast Cancer Chemotherapy) trial

JRCT ID: jRCTs071240036

Registered date:22/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 22/07/2024
• Target sample size: 230
• Study type: Interventional

Intervention(s)

Study arm: mouthwash with steroid mouthwash
Control arm: mouthwash with water

Outcome(s)

• Primary Outcome: the incidence of all-grade stomatitis using electric patient-reported outcomes (ePRO)
• Secondary Outcome: Percentage of patients with moderate or severe oral mucositis assessed by ePRO, duration of oral mucositis assessed by ePRO, percentage of patients with total and grade 2 or higher oral mucositisassessed by physician, QoL, percentage of patients who discontinued, postponed or reduced chemotherapy during the study participation period, mouthwash adherence, and oral infection, other adverse events of grade 3 or higher, and related items of health economic evaluation.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Patients diagnosed with invasive breast cancer by needle biopsy or surgery
2) Patients who are scheduled to receive AC or EC/AC or EC + pembrolizumab/dose dense AC or dose-dense EC/TC therapy
3) Patients who can complete the patient diary and questionnaire in the ePRO
4) Persons with a PS of 0-1
5) Persons aged between 18 and 80 years at the time consent is obtained.
6) Persons who have given written consent to participate in the study.

Exclude criteria

(1) Persons with breast cancer metastasis or recurrence
(2) Persons with oral mucositis before treatment
(3) Persons with oral wounds caused by dentures
(4) Women with pregnant or lactating
(5) Persons deemed inappropriate for inclusion in the study by the principal investigator.

Related Information

• Primary Sponsor: Kuba Sayaka
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development