Multicenter randomized phase II study prevention of chemotherapy induced stomatitis with the steroid component mouthwash in woman with breast cancer

JRCT ID: jRCTs071180022

Registered date:22/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 05/01/2018
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Control group: Patients will recieve chemotherapy every 3 week.
Interventional group: Beginning on day 1 of cycle1, patients will recieve chemotherapy with 10ml of dexamethazone 0.5 mg per 5 mL oral solution, swish for 2 min and spit, four times daily for 8 weeks.

Outcome(s)

• Primary Outcome: Incidence of all grade stomatitis
• Secondary Outcome: Incidence of stomatitis according grade, Incidence of dysgeusia, nutrition status, completion rates of chemotherapy, relative dose intensity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Female
• Include criteria: Patients who is going to have chemotherapy, patients without stomatitis
• Exclude criteria: Patients who have metastatic disease

Related Information

• Primary Sponsor: Eguchi Susumu
• Source(s) of Monetary Support: Nagasaki ken Medical association,Japan Cancer Society